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

NCT00648063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-12-01

No results posted yet for this study

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

DRUG

Letrozole Tablets 2.5 mg

2.5mg, single dose fasting

DRUG

Femara® Tablets 2.5 mg

2.5mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Lawrence Galitz, M.D. · SFBC International

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2005-12-31
Completion
2006-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648063 on ClinicalTrials.gov