Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Roxane Laboratories

ClinicalTrials.gov Identifier:

NCT01367626

First received: June 3, 2011

Last updated: May 22, 2012

Last verified: May 2012

History of Changes

Purpose

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

Condition	Intervention
Breast Cancer	Drug: letrozole

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

bioequivalence determined by statistical comparison Cmax [ Time Frame: 31 days ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	March 2008
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: letrozole 2.5 mg tablet	Drug: letrozole 2.5 mg tablet Other Name: Femara
Active Comparator: Fermara 2.5 mg tablet	Drug: letrozole 2.5 mg tablet Other Name: Femara

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367626

Locations

United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Alan K Copa, PharmD

PRAC Institute, Ltd.

More Information

No publications provided

Responsible Party:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT01367626 History of Changes
Other Study ID Numbers:	LETR-T25-PVFD-1
Study First Received:	June 3, 2011
Last Updated:	May 22, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

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