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

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648063
First received: March 30, 2008
Last updated: November 30, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Letrozole Tablets 2.5 mg
Drug: Femara® Tablets 2.5 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Fasting Bioequivalence Study of Letrozole Tablets (2.5 mg; Mylan) and Femara® Tablets (2.5 mg; Novartis) in Healthy Postmenopausal Female Volunteers

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [ Time Frame: Blood collections through 216 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2005
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Letrozole Tablets 2.5 mg
Drug: Letrozole Tablets 2.5 mg
2.5mg, single dose fasting
Active Comparator: 2
Femara® Tablets 2.5 mg
Drug: Femara® Tablets 2.5 mg
2.5mg, single dose fasting

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 40 years or older.
  2. Sex: Females only.
  3. Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOAVAILABILITY PROTOCOLS).
  4. Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
  5. Baseline FSH and 17β-estradiol serum levels consistent with postmenopausal status confirmed within 72 hours of initiation of study medication (FSH greater than or equal to 40 mIU/mL; 17β-estradiol less than or equal to 31 pg/mL).
  6. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV tests, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.
  7. The physical examination shall include pelvic and breast exams.

    1. Pelvic findings should be consistent with hypoestrogenemia.
    2. A mammogram will be required if not performed within the last 12 months.
    3. A Papanicolaou ("Pap") smear will be required on subjects with an intact uterus and cervix if not performed within the last 6 months.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Social Habits:

    1. Use of any tobacco-containing products within 1 year of start of study.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. A positive test for any drug included in the urine drug screen.
    6. History of drug and/or alcohol abuse.
  3. Medications:

    1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
    2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
    3. Use hormonal replacement therapy within 3 months prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant chronic disease such as (but not limited to): 1. Thrombotic disorders. 2. Coronary artery or cerebrovascular disease. 3. Liver, kidney or gallbladder dysfunction/disorder(s). 4. Diabetes or any other endocrinological disease. 5. Estrogen-dependent neoplasia. 6. Postmenopausal uterine bleeding. 7. Endometrial hyperplasia.
    2. Acute illness at the time of either the pre-study medical evaluation or dosing.
    3. A positive HIV, Hepatitis B, or Hepatitis C test.
  5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
  7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  8. Allergy or hypersensitivity to letrozole, any of the inactive ingredients.
  9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00648063

Locations
United States, Florida
SFBC International
Miami, Florida, United States, 33181
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Lawrence Galitz, M.D. SFBC International
  More Information

Additional Information:
No publications provided

Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00648063     History of Changes
Other Study ID Numbers: LETR-05122
Study First Received: March 30, 2008
Last Updated: November 30, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014