An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative Oral Bioavailability Study Of Letrozole 2.5 mg Tablets (Test) of Dr.Reddy's Laboratories Ltd and Femara 2.5 mg Tablets (Reference)of Novartis Pharmaceuticals Corporation, USA In Healthy, Post Menopausal Women Subjects Under Fasting Conditions

Dr. Reddy's Laboratories Limited0 sites36 target enrollmentMarch 2008

ConditionsHealthy

InterventionsLetrozole

DrugsLetrozole

Overview

Phase: Phase 1
Intervention: Letrozole
Conditions: Healthy
Sponsor: Dr. Reddy's Laboratories Limited
Enrollment: 36
Primary Endpoint: Bioavailability based on Cmax and AUC parameters
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions.

Detailed Description

An Open Label, Balanced, Randomized,Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative oral bioavailability study in healthy, post menopausal women subjects under fasting conditions.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

May 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Dr. Reddy's Laboratories Limited

Eligibility Criteria

Inclusion Criteria

•Healthy post menopausal women within the age range of 40 to 69 years.
•A body mass index within 18-29.9 Kg/m2
•The postmenopausal status should be confirmed by
•Serum Estradiol concentration \<40 pg/mL.
•Serum follicle stimulating hormone (FSH) concentration \>30 IU/L.
•No vaginal bleeding for at least 1 year.
•Given written informed consent to participate in the study.
•Absence of disease markers of HIV 1 \& 2, hepatitis B \& C virus and RPR.
•Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
•A normal 12-lead ECG.

Exclusion Criteria

•The subjects were excluded based on the following criteria.
•Subjects incapable of understanding the informed consent.
•History of suggestive of breast carcinoma, endometrial carcinoma or cervical carcinoma.
•History of suggestive of deep vein thrombosis and/or undiagnosed vaginal bleeding.
•History of thromboembolic disorders.
•History of seizures.
•History of any other major surgical procedure in the past 3 months.
•History of diabetes mellitus and systemic hypertension.
•Past history of anaphylaxis or angioedema.
•History of porphyria, Dubin-Johnson, Rotor syndrome or any other hyperbilirubinemia syndrome.