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Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01331447
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: exemestane Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions
Study Start Date : May 2004
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Exemestane


Intervention Details:
  • Drug: exemestane
    25 mg tablet
    Other Name: AROMASIN


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


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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.

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): NCT01331447


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.

Responsible Party: Elizabeth Ernst, Executive Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01331447     History of Changes
Other Study ID Numbers: EXEM-03
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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