Absorption, Bioavailability, Pharmacokinetics
Conditions
Keywords
Pharmacokinetics, Food Effect, Bioavailability, Megace ES
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.
Interventions
DRUGMegestrol acetate oral suspension 625 mg/5 mL
Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
Sponsors
SFBC Anapharm
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and extent of absorption | 120 hours (5 days) |
| 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 |
Countries
Canada
Outcome results
None listed