Evaluating the Effect of Food on Absorption of Megace ES
Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics; Bioavailability; Absorption
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.
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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Rate and extent of absorptionSafety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.
Eligibility
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
Locations and Contacts
SFBC Anapharm, Montreal (Quebec) H3X 2H9, Canada
Additional Information
International Journal of Nanomedicine
Starting date: June 2006
Last updated: August 18, 2015
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