Clinical trial NCT00638079: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Bioavailability
Absorption
Keywords: Pharmacokinetics
Food Effect
Bioavailability
Megace ES
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: SFBC Anapharm
First posted: 2008-03-18
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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

Primary outcomes:
measure: Rate and extent of absorption
timeFrame: 120 hours (5 days)
measure: Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.
timeFrame: signing of informed consent to 30 days after last study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal (Quebec)
country: Canada
facility: SFBC Anapharm
Study officials:
affiliation: SFBC Anapharm
name: Benoit Deschamps, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endo Pharmaceuticals
name: Todd Kirby, PhD
role: STUDY_DIRECTOR
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.