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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. SFBC Anapharm |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00638079 |
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.
Condition | Intervention | Phase |
---|---|---|
Pharmacokinetics Bioavailability |
Drug: Megestrol acetate oral suspension 625 mg/5 mL |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-availability Study |
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 |
Enrollment: | 24 |
Study Start Date: | June 2006 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
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
|
B: Active Comparator
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 following an overnight fast
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
SFBC Anapharm | |
Montreal (Quebec), Canada, H3X 2H9 |
Principal Investigator: | Benoit Deschamps, MD | SFBC Anapharm |
Study Director: | Donald D Cilla, PharmD | Par Pharmaceutical, Inc. |
Responsible Party: | Par Pharmaceutical, Inc ( VP Clinical & Medical Affairs ) |
Study ID Numbers: | PAR 100.1.C.003 |
Study First Received: | March 11, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00638079 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetics Food Effect Bioavailability Megace ES |
Antineoplastic Agents, Hormonal Contraceptive Agents Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants |
Healthy Megestrol Appetite Stimulants Megestrol Acetate |
Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants Reproductive Control Agents |
Megestrol Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Megestrol Acetate Appetite Stimulants |