## Protocol Section
### Identification Module
**NCT ID:** NCT00638079

**Brief Title:** Evaluating the Effect of Food on Absorption of Megace ES

**Official Title:** Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in Healthy Subjects

#### Organization Study ID Info
**ID:** PAR 100.1.C.003
#### Organization
**Class:** INDUSTRY
**Full Name:** Endo Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2006-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-04-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-07

**Type:** ACTUAL

#### Start Date
**Date:** 2006-06

**Status Verified Date:** 2015-08

#### Study First Post Date
**Date:** 2008-03-18
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-11
**Study First Submit QC Date:** 2008-03-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** SFBC Anapharm

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Endo Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.

### Conditions Module

**Conditions:**

- Pharmacokinetics

- Bioavailability

- Absorption

**Keywords:**

- Pharmacokinetics

- Food Effect

- Bioavailability

- Megace ES

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal

**Intervention Names:**

- Drug: Megestrol acetate oral suspension 625 mg/5 mL

**Label:** A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast

**Intervention Names:**

- Drug: Megestrol acetate oral suspension 625 mg/5 mL

**Label:** B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal

**Name:** Megestrol acetate oral suspension 625 mg/5 mL

**Other Names:**

- Megace ES

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- B

**Description:** Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast

**Name:** Megestrol acetate oral suspension 625 mg/5 mL

**Other Names:**

- Megace ES

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Rate and extent of absorption

**Time Frame:** 120 hours (5 days)

**Measure:** Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.

**Time Frame:** signing of informed consent to 30 days after last study visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32
* Healthy

Exclusion Criteria:

* History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors), or excretion of study drug
* History of or any current medical conditions that could affect subject safety
* History of frequent nausea or emesis, regardless of etiology
* Participation in a clinical drug study during the 30 days preceding the initial dose
* Significant illness during the 4 weeks preceding study entry
* Use of any medication, including vitamins/herbal/mineral supplements, during the 7 days preceding the initial dose
* Refusal or inability to abstain from food 10 hours proceeding and 4 hours following study drug administration, to consume the FDA high fat meal as directed, and to abstain from caffeine- or xanthine-containing beverages entirely during each confinement
* Any history of or current drug or alcohol abuse
* Prior alcohol intake exceeding the equivalent of 14 units/week (12 oz beer = 4 oz wine = 1.5 oz shot = 1 unit) on average, or consumption of any alcoholic beverages within 48 hours of study drug administration
* History of smoking\>25 cigarettes/day within 45 days of study drug administration
* Blood or blood products donated within 30 days prior to study drug administration, or anytime during the study, except as required by this protocol
* Positive results of urine drug screen, blood alcohol by a Breathalyzer test, hepatitis B surface antigen, hepatitis B surface antibody (unless immunized), or anti-HCV

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Montreal (Quebec)

**Country:** Canada

**Facility:** SFBC Anapharm

**Zip:** H3X 2H9

#### Overall Officials

**Official 1:**

**Affiliation:** SFBC Anapharm

**Name:** Benoit Deschamps, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Endo Pharmaceuticals

**Name:** Todd Kirby, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10.

**PMID:** 19774117

#### See Also Links

**Label:** International Journal of Nanomedicine

**URL:** http://www.dovepress.com/international-journal-of-nanomedicine-journal

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000003278

- Term: Contraceptives, Oral, Hormonal

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019167

- Term: Appetite Stimulants

- ID: D000000697

- Term: Central Nervous System Stimulants

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

### Intervention Browse Module - Browse Leaves

- ID: M11518

- Name: Megestrol

- Relevance: HIGH

- As Found: January

- ID: M21272

- Name: Megestrol Acetate

- Relevance: HIGH

- As Found: Caucasian

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6502

- Name: Contraceptives, Oral, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008535

- Term: Megestrol

- ID: D000019290

- Term: Megestrol Acetate

### Misc Info Module

- Version Holder: 2024-05-24
