Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

N/ACompletedNCT01331447

Roxane Laboratories12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

exemestaneDRUG

25 mg tablet

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

BioKinetic Clinical Applications, Inc.

Springfield, Missouri, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 21 days

Data from ClinicalTrials.gov

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