## Protocol Section
### Identification Module
**NCT ID:** NCT05468879

**Brief Title:** Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

**Official Title:** Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

#### Organization Study ID Info
**ID:** 540/STD/PML/2020
#### Organization
**Class:** INDUSTRY
**Full Name:** PT Harsen Laboratories
### Status Module
#### Completion Date
**Date:** 2021-01-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-07-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-10-23

**Type:** ACTUAL

#### Start Date
**Date:** 2020-09-21

**Type:** ACTUAL

**Status Verified Date:** 2022-07

#### Study First Post Date
**Date:** 2022-07-21
**Type:** ACTUAL
**Study First Submit Date:** 2022-07-19
**Study First Submit QC Date:** 2022-07-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** PT Pharma Metric Labs

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** PT Harsen Laboratories

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT. Aventis Indonesia Pharma, Indonesia.

**Detailed Description:** The study was conducted following an oral administration of one tablet of the test drug (3 mg Glimepiride Tablet) or one tablet of the reference drug (3 mg Amaryl® Tablet ). Blood samples were drawn before dosing (0 h) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration. The entire subjects were given 60 mL of 20% glucose solution to minimize hypoglycemic effects at 15, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 and 4 hours after drug administration. Following a washout period of one week, this procedure was repeated using the alternate drug. The plasma concentrations of glimepiride were determined by means of LC-MS/MS system. The LLOQ is 1.99 ng/mL of glimepiride. The pharmacokinetic parameters used in this study were area under the concentration-time curve of glimepiride from time zero to 30 hours (AUCt), area under the concentration-time curve from time zero to infinite (AUCinf), maximum concentration (Cmax), time required to reach the maximum concentration (tmax) and the elimination half life (t½).

### Conditions Module

**Conditions:**

- Drug Use

**Keywords:**

- Bioequivalence study

- Glimepiride

- Indonesia

- cross-over design study

- pharmacokinetics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Randomized, single blind, two-period, single dose, cross-over study with one week washout period under fasted condition

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received Glimepiride 3 mg Tablet with 240 mL of 20% glucose solution

**Intervention Names:**

- Drug: Glimepiride

**Label:** Glimepiride 3 mg Tablet

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received Amaryl® 3 mg tablet (Glimepiride 3 mg) with 240 mL of 20% glucose solution

**Intervention Names:**

- Drug: Amaryl®

**Label:** Amaryl® 3 mg tablet

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Glimepiride 3 mg Tablet

**Description:** Glimepiride is a sulfonylurea, indicated as an adjunct to proper dietary management, exercise and weight reduction to lower the blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone.

**Name:** Glimepiride

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Amaryl® 3 mg tablet

**Description:** Amaryl®

**Name:** Amaryl®

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 90% Confidence Interval

**Measure:** Maximum plasma concentration (Cmax)

**Time Frame:** before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration

**Description:** 90% Confidence Interval

**Measure:** Area Under Curve from 0 to 30 hours (AUCt)

**Time Frame:** before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration

#### Secondary Outcomes

**Description:** Pharmacokinetics Parameter

**Measure:** Maximum plasma concentration (Cmax)

**Time Frame:** before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration

**Description:** Pharmacokinetics Parameter

**Measure:** Area Under Curve from 0 to 30 hours (AUCt)

**Time Frame:** before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* healthy male and female
* had read the subject information and signed informed consent documents
* were age between 18 to 55 years
* had body mass index between 18 to 25 kg/m2
* had a normal electrocardiogram
* had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)
* had normal heart rate (ranged between 60 to 100 bpm)
* have no significant disease in medical history; have no significant abnormal values in laboratory and physical examination during screening
* had acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

* Pregnant and/or nursing woman.
* Those with a history of contraindication or hypersensitivity to glimepiride, other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction.
* Those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
* Those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
* Those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.
* Those who had participated in any clinical study within 3 months prior to the study (\< 90 days).
* Those who donated or lost 300 mL (or more) of blood within 3 months prior to the study.
* Those who smoked more than 10 cigarettes a day
* Those with a history of travelling to another city within the last 14 days
* Those with a history of direct contact with a COVID-19 positive person in the subject's neighborhood
* Those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea within the last 14 days
* Those who reactive to anti SARS CoV-2 test
* Those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
* Those with a history of drug or alcohol abused within 12 months prior to screening for this study
* Those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jakarta

**Country:** Indonesia

**Facility:** PT Pharma Metric Labs

**State:** DKI Jakarta

**Zip:** 10520

### References Module

#### References

**Citation:** Liu Y, Zhang MQ, Zhu JM, Jia JY, Liu YM, Liu GY, Li S, Weng LP, Yu C. Bioequivalence and pharmacokinetic evaluation of two formulations of glimepiride 2 mg: a single-dose, randomized-sequence, open-label, two-way crossover study in healthy Chinese male volunteers. Clin Ther. 2010 May;32(5):986-95. doi: 10.1016/j.clinthera.2010.04.016.

**PMID:** 20685507

**Citation:** Jung SH, Chae JW, Song BJ, Kwona KI. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Iran J Pharm Res. 2014 Spring;13(2):365-71.

**PMID:** 25237332

**Citation:** Zhu J, Li Y, Xiang Y, Zhou L, Li Y. Magnetic solid phase extraction followed with LC-MS/MS for determination of glimepiride in beagle dog plasma and its application to bioequivalence study. J Pharm Biomed Anal. 2020 May 30;184:113180. doi: 10.1016/j.jpba.2020.113180. Epub 2020 Feb 15.

**PMID:** 32092631

**Citation:** Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.

**PMID:** 17252706

#### See Also Links

**Label:** Amaryl® (Glimepiride) Tablet 1,2, and 4 mg, Product Monograph

**URL:** https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2022-08-05

- Date Unknown: Unknown

#### Event: RESET

- Date: 2023-07-06

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M252104

- Name: Glimepiride

- Relevance: HIGH

- As Found: Correlative

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000057619

- Term: Glimepiride

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2022-08-05

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2022-08-05

- Reset Date: 2023-07-06

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
