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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00638079
Other study ID # PAR 100.1.C.003
Secondary ID
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


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
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