Evaluating the Effect of Food on Absorption of Megace ES

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Endo Pharmaceuticals
• Collaborator: SFBC Anapharm
• Treatments: Megestrol; Megestrol Acetate

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