Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

Phase 1CompletedNCT01367626

Roxane Laboratories28 enrolled

Overview

The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

letrozoleDRUG

2.5 mg tablet

letrozoleDRUG

2.5 mg tablet

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 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 letrozole or any comparable or similar product.

Locations (1)

PRACS Institute, Ltd.

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 31 days

Data from ClinicalTrials.gov

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