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Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01331434
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011

April 6, 2011
April 7, 2011
October 2004
October 2004   (final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01331434 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions
A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: exemestane
25 mg tablet
Other Name: AROMASIN
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
October 2004
October 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to exemestane or any comparable or similar product.
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01331434
EXEM-02
No
Elizabeth Ernst, Executive Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Dennis N Morrison, D.O. Bio-Kinetic Clinical Applications, Inc.
Roxane Laboratories
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP