Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT01367652
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	2.5 mg tablet
Femara	Letrozole	2.5 mg tablet

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	31 days

Trial Locations

Locations (1)

PRACS Institute, Ltd.; 🇺🇸 Fargo, North Dakota, United States