Evaluating the Effect of Food on Absorption of Megace ES

Pharmacokinetics Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638079
• Other study ID #: PAR 100.1.C.003
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2008
• Last updated: April 18, 2016
• Start date: June 2006
• Est. completion date: July 2006

Study information

• Verified date: August 2015
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Absorption
• Bioavailability
• Pharmacokinetics

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	SFBC Anapharm	Montreal (Quebec)

Sponsors (2)

Lead Sponsor	Collaborator
Endo Pharmaceuticals	SFBC Anapharm

Country where clinical trial is conducted

Canada, 

References & 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. Epub 2009 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and extent of absorption		120 hours (5 days)	No
Primary	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	Yes

External Links

•   International Journal of Nanomedicine