Evaluating the Effect of Food on Absorption of Megace ES

Endo Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Absorption; Bioavailability; Pharmacokinetics

Treatments: Drug: Megestrol acetate oral suspension 625 mg/5 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638079

PAR 100.1.C.003

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

A

Experimental group

Description:

Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal

Treatment:

Drug: Megestrol acetate oral suspension 625 mg/5 mL

Drug: Megestrol acetate oral suspension 625 mg/5 mL

B

Active Comparator group

Description:

Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast

Treatment:

Drug: Megestrol acetate oral suspension 625 mg/5 mL

Drug: Megestrol acetate oral suspension 625 mg/5 mL