Evaluating the Effect of Food on Absorption of Megace ES

This study has been completed.
Sponsor:
Collaborator:
SFBC Anapharm
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00638079
First received: March 11, 2008
Last updated: March 5, 2010
Last verified: March 2010
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 15, 2014