## Protocol Section
### Identification Module
**NCT ID:** NCT00840879

**Brief Title:** Meloxicam 15 mg Tablets Under Non-Fasting Conditions

**Official Title:** A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Meloxicam 15 mg Tablets Versus Mobic® 15 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects

#### Organization Study ID Info
**ID:** 2825
#### Organization
**Class:** INDUSTRY
**Full Name:** Teva Pharmaceuticals USA
### Status Module
#### Completion Date
**Date:** 2004-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-09-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-09-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2004-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2009-08-04

**Type:** ESTIMATED

**Results First Submit Date:** 2009-06-30

**Results First Submit QC Date:** 2009-06-30

#### Start Date
**Date:** 2004-02

**Status Verified Date:** 2009-09

#### Study First Post Date
**Date:** 2009-02-10
**Type:** ESTIMATED
**Study First Submit Date:** 2009-02-06
**Study First Submit QC Date:** 2009-02-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Teva Pharmaceuticals USA

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions.

**Detailed Description:** Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Bioequivalence

- Healthy Subjects

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period

**Intervention Names:**

- Drug: Meloxicam 15 mg Tablets

**Label:** Meloxicam

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period

**Intervention Names:**

- Drug: Mobic® 15 mg Tablets

**Label:** Mobic®

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Meloxicam

**Description:** 1 x 15 mg, single-dose fed

**Name:** Meloxicam 15 mg Tablets

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Mobic®

**Description:** 1 x 15 mg, single-dose fed

**Name:** Mobic® 15 mg Tablets

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Bioequivalence based on Cmax

**Measure:** Cmax - Maximum Observed Concentration

**Time Frame:** Blood samples collected over 96 hour period

**Description:** Bioequivalence based on AUC0-inf

**Measure:** AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

**Time Frame:** Blood samples collected over 96 hour period

**Description:** Bioequivalence based on AUC0-t

**Measure:** AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

**Time Frame:** Blood samples collected over 96 hour period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non tobacco user for at least 90 days prior to pre-study medical).
* Body mass Index (BMI = weight/height²) greater than or equal to 18.5 kg/m² and less than or equal to 29.9 kg/m².
* Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
* Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.5ºC).
* Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
* No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
* Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.

Exclusion Criteria:

* Known history of hypersensitivity to meloxicam (for example Mobic®), or related drugs such as any other non-steroidal anti-inflammatory drugs (NSAID) such as acetylsalicyclic acid (e.g. Excedrin®, Aspirin®), ibuprofen (e.g. Motrin®), celecoxib (e.g. Celebrex®), Feldene®, Indocin®, Naprosyn®, Vioxx®, Toradol®, Clinoril®, Tolectin®, or Lodine®.
* Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, or liver disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
* Any history or presence of peptic ulcer disease, gastrointestinal bleeding, or kidney disease.
* Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* Any clinically significant illness during the last four weeks prior to entry into this study.
* Presence of any significant physical or organ abnormality.
* Any subject with history of drug abuse.
* Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
* Use of any prescription medication within 14 days preceding entry into this study.
* Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
* Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
* Female subjects: presence of pregnancy or lactation.
* Female subjects at risk of becoming pregnant must consent to using two medically acceptable methods of contraception throughout the entire study, including the washout period and for one month after the completion of the study. Medically acceptable barrier methods of contraception that may be used by the subject and/or partner include diaphragm with spermicide, IUD, condom with foam, and vaginal spermicidal suppository. Complete abstinence can be used alone as a method of contraception.
* Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR or within the lockout period specified by a previous study conducted at BCR.
* Participation in a clinical trial with an investigational drug within 30 days preceding this study.
* Any subject who has donated blood within 56 days preceding this study.
* Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
* Any subject with a recent (less than one year) history of alcohol abuse.
* Significant or recent history of asthma (after 12 years of age), or familial history of asthma or aspirin-sensitive asthma, sever bronchospasm, nasal polyps or chronic sinusitis.
* Intolerance to venipuncture.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toronto

**Country:** Canada

**Facility:** Biovail Contract Research

**State:** Ontario

**Zip:** M1L4S4

#### Overall Officials

**Official 1:**

**Affiliation:** Biovail Contract Research

**Name:** Paul Y. Tam, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000052246

- Term: Cyclooxygenase 2 Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1713

- Name: Meloxicam

- Relevance: HIGH

- As Found: Onset of

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27009

- Name: Cyclooxygenase 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077239

- Term: Meloxicam

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Group ID:** BG001

**Value:** 14

**Group ID:** BG002

**Value:** 28

**Units:** Participants

### Group

**ID:** BG000

**Title:** Meloxicam (Test) First

**Description:** Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period

### Group

**ID:** BG001

**Title:** Mobic® (Reference) First

**Description:** Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 21

**Class Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 5

**Class Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Asian

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 28

**Class Title:** Canada

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Principal Investigator is not permitted to discuss or publish trial results.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** clinicaltrialqueries@tevausa.com
**Organization:** Teva Pharmaceuticals USA
**Phone:** 1-866-384-5525
**Title:** Manager, Biopharmaceutics
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 90.96
**CI Number of Sides:** 
**CI Percentage Value:** 90
**CI Upper Limit:** 105.90
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Bioequivalence is established when 90% Confidence Interval falls within 80-125.
**Group Description:** 
**Non-Inferiority Comment:** Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Test/Ref Ratio of LS Means x 100
**Parameter Value:** 98.15
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 91.82
**CI Number of Sides:** 
**CI Percentage Value:** 90
**CI Upper Limit:** 101.07
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Bioequivalence is established when 90% Confidence Interval falls within 80-125.
**Group Description:** 
**Non-Inferiority Comment:** Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Test/Ref Ratio of LS Means x 100
**Parameter Value:** 96.34
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 93.31
**CI Number of Sides:** 
**CI Percentage Value:** 90
**CI Upper Limit:** 102.42
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Bioequivalence is established when 90% Confidence Interval falls within 80-125.
**Group Description:** 
**Non-Inferiority Comment:** Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Test/Ref Ratio of LS Means x 100
**Parameter Value:** 97.76
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Anticipated Posting Date:** 2009-06
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** 1.32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.29
- **Upper Limit:** 
- **Value:** 1.36
**Title:** 
#### Outcome Measure 2
**Anticipated Posting Date:** 2009-06
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.88
- **Upper Limit:** 
- **Value:** 40.50
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 17.62
- **Upper Limit:** 
- **Value:** 42.38
**Title:** 
#### Outcome Measure 3
**Anticipated Posting Date:** 2009-06
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.33
- **Upper Limit:** 
- **Value:** 37.11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.70
- **Upper Limit:** 
- **Value:** 38.00
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Bioequivalence based on Cmax
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.
**Reporting Status:** POSTED
**Time Frame:** Blood samples collected over 96 hour period
**Title:** Cmax - Maximum Observed Concentration
**Type:** PRIMARY
**Unit of Measure:** µg/mL
##### Group
**Description:** Meloxicam 15 mg Tablet (test) dosed in either period
**ID:** OG000
**Title:** Meloxicam
##### Group
**Description:** Mobic® 15 mg Tablet (reference) dosed in either period
**ID:** OG001
**Title:** Mobic®
#### Outcome Measure 2
**Description:** Bioequivalence based on AUC0-inf
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.
**Reporting Status:** POSTED
**Time Frame:** Blood samples collected over 96 hour period
**Title:** AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
**Type:** PRIMARY
**Unit of Measure:** µg*h/mL
##### Group
**Description:** Meloxicam 15 mg Tablet (test) dosed in either period
**ID:** OG000
**Title:** Meloxicam
##### Group
**Description:** Mobic® 15 mg Tablet (reference) dosed in either period
**ID:** OG001
**Title:** Mobic®
#### Outcome Measure 3
**Description:** Bioequivalence based on AUC0-t
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.
**Reporting Status:** POSTED
**Time Frame:** Blood samples collected over 96 hour period
**Title:** AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
**Type:** PRIMARY
**Unit of Measure:** µg*h/mL
##### Group
**Description:** Meloxicam 15 mg Tablet (test) dosed in either period
**ID:** OG000
**Title:** Meloxicam
##### Group
**Description:** Mobic® 15 mg Tablet (reference) dosed in either period
**ID:** OG001
**Title:** Mobic®
### Participant Flow Module
#### Group
**Description:** Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
**ID:** FG000
**Title:** Meloxicam (Test) First
#### Group
**Description:** Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
**ID:** FG001
**Title:** Mobic® (Reference) First
#### Period
**Title:** First Intervention
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Washout: 14 Days
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Second Intervention
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True