MedTrace Logo

Evaluating the Effect of Food on Absorption of Megace ES

NCT00638079 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-04-19

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Bioavailability
  • Absorption

Interventions

DRUG

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

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

Sponsors & Collaborators

  • SFBC Anapharm

    collaborator INDUSTRY

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Benoit Deschamps, MD · SFBC Anapharm

  • Todd Kirby, PhD · Endo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00638079 on ClinicalTrials.gov