NCT01372982

Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fed Conditions

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 Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Female
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2011-06-14
• Last updated: 2011-06-14