Evaluating the Effect of Food on Absorption of Megace ES

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Bioavailability; Absorption
• Intervention / Treatment: Drug: Megestrol acetate oral suspension 625 mg/5 mL; Drug: Megestrol acetate oral suspension 625 mg/5 mL

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal (Quebec), Canada, H3X 2H9
    • SFBC Anapharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal	Drug: Megestrol acetate oral suspension 625 mg/5 mL; Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal; Other Names: Megace ES; Drug: Megestrol acetate oral suspension 625 mg/5 mL; Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast; Other Names: Megace ES
Active Comparator: B; Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast	Drug: Megestrol acetate oral suspension 625 mg/5 mL; Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal; Other Names: Megace ES; Drug: Megestrol acetate oral suspension 625 mg/5 mL; Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast; Other Names: Megace ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and extent of absorption	120 hours (5 days)
Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.	signing of informed consent to 30 days after last study visit

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Collaborators: SFBC Anapharm
• Investigators: Principal Investigator: Benoit Deschamps, MD, SFBC Anapharm; Study Director: Todd Kirby, PhD, Endo Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Helpful Links

• International Journal of Nanomedicine

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioavailability; Food Effect; Megace ES
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Central Nervous System Stimulants; Appetite Stimulants; Megestrol; Megestrol Acetate
• Other Study ID Numbers: PAR 100.1.C.003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No