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Completed

NCT Number: NCT00638079

Evaluating the Effect of Food on Absorption of Megace ES

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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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SFBC Anapharm

Montreal (Quebec), H3X 2H9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Megestrol acetate oral suspension 625 mg/5 mL

Drug

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

Other names: Megace ES

Primary outcomes

  1. Rate and extent of absorption

    Time frame: 120 hours (5 days)

  2. Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.

    Time frame: signing of informed consent to 30 days after last study visit

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Collaborators

  • SFBC Anapharm

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 18, 2008
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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