Evaluating the Effect of Food on Absorption of Megace ES - Full Text View

Sponsor:	Par Pharmaceutical, Inc.
Collaborator:	SFBC Anapharm
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00638079

Purpose

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.

Condition	Intervention	Phase
Pharmacokinetics Bioavailability	Drug: Megestrol acetate oral suspension 625 mg/5 mL	Phase I

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

Resource links provided by NLM:

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and extent of absorption [ Time Frame: 120 hours (5 days) ] [ Designated as safety issue: No ]
Safety [ Time Frame: signing of informed consent to 30 days after last study visit ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	June 2006
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) 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 with a high fat meal Other Name: Megace ES
Active Comparator: B Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast	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 Other Name: Megace ES

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638079

Locations

Canada
SFBC Anapharm
Montreal (Quebec), Canada, H3X 2H9

Sponsors and Collaborators

Par Pharmaceutical, Inc.

SFBC Anapharm

Investigators

Principal Investigator:	Benoit Deschamps, MD	SFBC Anapharm
Study Director:	Donald D Cilla, PharmD	Par Pharmaceutical, Inc.

More Information

Additional Information:

International Journal of Nanomedicine This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	VP Clinical & Medical Affairs, Par Pharmaceutical, Inc
ClinicalTrials.gov Identifier:	NCT00638079 History of Changes
Other Study ID Numbers:	PAR 100.1.C.003
Study First Received:	March 11, 2008
Last Updated:	March 5, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

Pharmacokinetics
Food Effect
Bioavailability
Megace ES

Additional relevant MeSH terms:

Megestrol Acetate
Megestrol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants

Physiological Effects of Drugs
Central Nervous System Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012