Status:
COMPLETED
Evaluating the Effect of Food on Absorption of Megace ES
Lead Sponsor:
Endo Pharmaceuticals
Collaborating Sponsors:
SFBC Anapharm
Conditions:
Pharmacokinetics
Bioavailability
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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
- Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32
- Healthy
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00638079
Start Date
June 1 2006
End Date
July 1 2006
Last Update
April 19 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SFBC Anapharm
Montreal (Quebec), Canada, H3X 2H9