Evaluating the Effect of Food on Absorption of Megace ES

NCT00638079 | Completed Phase 1

• 1 other identifier: PAR 100.1.C.003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetics; Food Effect; Bioavailability; Megace ES

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Megestrol acetate oral suspension 625 mg/5 mL

B

ACTIVE COMPARATOR

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

Drug: Megestrol acetate oral suspension 625 mg/5 mL

Interventions

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

Also known as: Megace ES

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32
• Healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead
• SFBC Anapharm: collaborator

Study Sites (1)

SFBC Anapharm

Montreal (Quebec), H3X 2H9, Canada

Location

Related Publications (1)

• Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10.

  PMID: 19774117 RESULT

Related Links

• International Journal of Nanomedicine

MeSH Terms

Interventions

Megestrol Acetate

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Benoit Deschamps, MD

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

• Todd Kirby, PhD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: June 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 19, 2016

Record last verified: 2015-08

Locations

CA (1)