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Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01367626
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Study Description
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Brief Summary:
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: letrozole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Letrozole
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 31 days ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01367626     History of Changes
Other Study ID Numbers: LETR-T25-PVFD-1
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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