Evaluating the Effect of Food on Absorption of Megace ES

Condition(s) targeted: Pharmacokinetics; Bioavailability

Intervention: Megestrol acetate oral suspension 625 mg/5 mL (Drug); Megestrol acetate oral suspension 625 mg/5 mL (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Benoit Deschamps, MD, Principal Investigator, Affiliation: SFBC Anapharm
Donald D Cilla, PharmD, Study Director, Affiliation: Par Pharmaceutical, Inc.

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.

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

Study design: Other, Randomized, Open Label, Crossover Assignment, Bio-availability Study

Primary outcome:

Rate and extent of absorption

Safety

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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

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

Starting date: June 2006
Ending date: July 2006
Last updated: March 11, 2008