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Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331421
First Posted: April 8, 2011
Last Update Posted: April 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Roxane Laboratories
  Purpose
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions

Condition Intervention
Breast Cancer Drug: exemestane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 days ]

Enrollment: 48
Study Start Date: July 2004
Study Completion Date: August 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: exemestane
    25 mg tablet
    Other Name: AROMASIN
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331421


Locations
United States, Missouri
BioKinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Dennis N Morrison, D.O. Bio-Kinetic Clinical Applications, Inc.
  More Information

Responsible Party: Elizabeth Ernst, Executive Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01331421     History of Changes
Other Study ID Numbers: EXEM-01
First Submitted: April 6, 2011
First Posted: April 8, 2011
Last Update Posted: April 8, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs