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

NCT01372982 | Completed Phase 1 DMC

• 1 other identifier: 033/08
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioavailability based on Cmax and AUC parameters

  3 Months

Study Arms (2)

Femara

ACTIVE COMPARATOR

Drug: Letrozole

Letrozole

EXPERIMENTAL

Drug: Letrozole

Interventions

Letrozole DRUG

Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited

Also known as: Femara® Tablets 2.5 mg

Femara; Letrozole

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ofHIV 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 l2-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.

You may not qualify if:

• 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,haematological, 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• A. Jaya Chandra Reddy, FRCS

  Trident Life Sciences Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 14, 2011
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 14, 2011

Record last verified: 2011-06