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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
History of Changes
  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:

Drug Information available for: Oxandrolone
U.S. FDA Resources

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
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:
Oxandrolone
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on June 18, 2013