Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01331447
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	21 days

Trial Locations

Locations (1)

BioKinetic Clinical Applications, Inc.; 🇺🇸 Springfield, Missouri, United States