Pharmacokinetics Clinical Trial
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
Verified date | August 2015 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | SFBC Anapharm | Montreal (Quebec) |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals | SFBC Anapharm |
Canada,
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. Epub 2009 Sep 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate and extent of absorption | 120 hours (5 days) | No | |
Primary | Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs. | signing of informed consent to 30 days after last study visit | Yes |
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