Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01375452
First received: June 16, 2011
Last updated: June 23, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Letrozole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative Oral Bioavailability Study Of Letrozole 2.5 mg Tablets (Test) of Dr.Reddy's Laboratories Ltd and Femara 2.5 mg Tablets (Reference)of Novartis Pharmaceuticals Corporation, USA In Healthy, Post Menopausal Women Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability based on Cmax and AUC parameters [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femara Drug: Letrozole
Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
Other Name: Femara® Tablets 2.5 mg
Experimental: Letrozole Drug: Letrozole
Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
Other Name: Femara® Tablets 2.5 mg

Detailed Description:

An Open Label, Balanced, Randomized,Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative oral bioavailability study in healthy, post menopausal women subjects under fasting conditions.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy post menopausal women within the age range of 40 to 69 years.

  • A body mass index within 18-29.9 Kg/m2
  • The postmenopausal status should be confirmed by
  • Serum Estradiol concentration <40 pg/mL.
  • Serum follicle stimulating hormone (FSH) concentration >30 IU/L.
  • No vaginal bleeding for at least 1 year.
  • Given written informed consent to participate in the study.
  • Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and RPR.
  • Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
  • A normal 12-lead ECG.
  • A normal chest X-ray (PA view) with in six months before the date of dosing.
  • Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol.
  • No history or no evidence of hypersensitivity/idiosyncratic reaction to Letrozole and related drugs or peanut products or other ingredients of the Letrozole formulation.
  • No history of significant systemic diseases.
  • Non-smokers.
  • No history of psychiatric disorders.
  • No donation of blood (one unit or 350 mL) within 56 days prior to study check- in.
  • No history of addiction to any recreational drug or drug dependence.
  • No participation in any clinical study within the past 56 days.
  • No receipt of any prescription drugs within 4 weeks or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations vitamins and natural products used for therapeutic benefits) within 14 days prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks.
  • No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
  • No family history of neurological disorders.
  • Not consumed alcohol and xanthine containing food and beverages, (chocolates, tea, coffee or cola drinks) cigarettes and tobacco products, for at least 48 hours, prior to study check-in.
  • Not consumed grape fruit containing food or beverages (mosumbi/sweet lime) or poppy containing foods within the 7 days prior to check-in of both the periods.
  • Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines, Cannabinoids and Barbiturates) in urine during the each period of study check-in.
  • Negative alcohol breathe analysis during the each period of study check-in.

Exclusion Criteria:

The subjects were excluded based on the following criteria.

  • Subjects incapable of understanding the informed consent.
  • History of suggestive of breast carcinoma, endometrial carcinoma or cervical carcinoma.
  • History of suggestive of deep vein thrombosis and/or undiagnosed vaginal bleeding.
  • History of thromboembolic disorders.
  • History of seizures.
  • History of any other major surgical procedure in the past 3 months.
  • History of diabetes mellitus and systemic hypertension.
  • Past history of anaphylaxis or angioedema.
  • History of porphyria, Dubin-Johnson, Rotor syndrome or any other hyperbilirubinemia syndrome.
  • History of otosclerosis exacerbated during pregnancy.
  • History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic,hematological, gastrointestinal, endocrine or immunological diseases.
  • Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study{one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit}.
  • History of difficulty with donating blood or difficulty in accessibility of veins.
  • An unusual or abnormal diet e.g. low sodium diet, for two weeks prior to receiving any medication and through out subject's participation in the study, for whatever reason e.g. because of fasting due to religious reasons.
  • Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
  • If any Dysplastic changes in the Papanicolaou Smear.
  • Female volunteers demonstrating a positive pregnancy test.
  • Female volunteers who are currently breast-feeding.
  • History of problem in swallowing tablet.
  • Used an oral contraceptive containing estrogens or progesterone, or any form of hormonal therapy or intake of HRT and pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 6 months of the start of the study.
  • History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the-in house-stay.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375452

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: A. Jaya Chandra Reddy, FRCS Trident Life Sciences Ltd
  More Information

No publications provided

Responsible Party: Dr. Ramesh Mullangi -Director, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01375452     History of Changes
Other Study ID Numbers: 032/08
Study First Received: June 16, 2011
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014