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: January 17, 2014

Last verified: January 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: letrozole	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (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: Malnutrition

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 ]


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 (Adult)
Sexes 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

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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


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:	January 17, 2014

Additional relevant MeSH terms:


Letrozole Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017

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