NCT00648063

Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg

Single-Dose Fasting Bioequivalence Study of Letrozole Tablets (2.5 mg; Mylan) and Femara® Tablets (2.5 mg; Novartis) in Healthy Postmenopausal Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Letrozole Tablets 2.5 mg	2.5mg, single dose fasting
DRUG	Femara® Tablets 2.5 mg	2.5mg, single dose fasting

Timeline

• Start date: 2005-11-01
• Primary completion: 2005-12-01
• Completion: 2006-01-01
• First posted: 2008-04-01
• Last updated: 2009-12-01

Locations

1 site across 1 country: United States