Evaluating the Effect of Food on Absorption of Megace ES

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-07-31

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.

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Detailed Description

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Conditions

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Pharmacokinetics Bioavailability Absorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

Megestrol acetate oral suspension 625 mg/5 mL

Intervention Type DRUG

Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal

B

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

Group Type ACTIVE_COMPARATOR

Megestrol acetate oral suspension 625 mg/5 mL

Intervention Type DRUG

Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast

Interventions

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Megestrol 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

Intervention Type DRUG

Megestrol acetate oral suspension 625 mg/5 mL

Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast

Intervention Type DRUG

Other Intervention Names

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Megace ES Megace ES

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes