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Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367652
First Posted: June 7, 2011
Last Update Posted: January 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxane Laboratories
  Purpose
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted 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 Fasted Conditions

Resource links provided by NLM:


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: Femara
2.5 mg tablet
Drug: Letrozole
2.5 mg tablet
Other Name: Femara

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367652


Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Alan Copa, PharmD PRACS Institute, Ltd.
  More Information

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01367652     History of Changes
Other Study ID Numbers: LETR-T25-PVFS-1
First Submitted: June 3, 2011
First Posted: June 7, 2011
Last Update Posted: January 20, 2014
Last Verified: January 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