Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00652886
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: April 2008
  Purpose

-To compare the single dose bioavailability of Kali and BTG


Condition Intervention Phase
To Determine the Bioequivalence Under Fasting Conditions
Drug: Oxandrolone
Drug: Oxandrin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Compare the Relative Bioavailability of Oxandrolone 10mg Tablets With That of OXANDRIN 10 mg Tablets Following a Single Oral Dose(1*10 mg Tablet) in Healthy, Adult Subjects Under Fasting Conditions.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2005
Study Completion Date: June 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received Kali's products under fasting conditions
Drug: Oxandrolone
Tablets, 10mg, single-dose
Other Name: Oxandrin
Active Comparator: B
Subjects received BTG products under fasting conditions
Drug: Oxandrin
tablets, 10mg, single-dose
Other Name: Oxandrolone

Detailed Description:

-To compare the bioavailability of Oxandrolone 10mg tablets with that of OXANDRIN 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children.
  • Each subject shall be given a general physical examination within 28days of the initiation study.
  • At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
  • Each female subject will be given a serum test as part of the pregnancy study screening process.
  • Clinical laboratory measurements will include Hematology, Clinical Chemistry, Urine Analysis, HIV Screen,hepatitis-B, C screen and Drugs of abuse Screen

Exclusion Criteria:

  • Subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study.
  • Subjects with any history of breast or prostate cancer will not be eligible to participate in this study.
  • Subjects who have a history of allergic response to the class of drug being tested will be excluded from the study.
  • Subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate.
  • Subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are not able to bear children will not be allowed to participate.
  • Female subjects with positive or inconclusive results will be withdrawn from the study.
  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: NCT00652886

Locations
United States, Missouri
Gateway Medical Research, Inc
St.Charles, Missouri, United States, 63301
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Cetero Research, San Antonio
Investigators
Principal Investigator: Steve Herrmann Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Dr. Alfred Elvin, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00652886     History of Changes
Other Study ID Numbers: B053205
Study First Received: April 1, 2008
Last Updated: April 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence, Oxandrolone,fasting

Additional relevant MeSH terms:
Disease
Pathologic Processes
Oxandrolone
Anabolic Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014