Evaluating the Effect of Food on Absorption of Megace ES

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacokinetics, Bioavailability, Absorption

Intervention / Treatment
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* Drug: Megestrol acetate oral suspension 625 mg/5 mL
* Drug: Megestrol acetate oral suspension 625 mg/5 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal | Drug: Megestrol acetate oral suspension 625 mg/5 mL<br>* Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal<br>* Other names: Megace ES;|
| Active Comparator: B<br>Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast | Drug: Megestrol acetate oral suspension 625 mg/5 mL<br>* Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast<br>* Other names: Megace ES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Food Effect, Bioavailability, Megace ES