Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions

NCT ID: NCT01124162

Last Updated: 2010-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2003-11-30

Brief Summary

The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Generic Test Product

Losartan 100mg Tablets

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

100 mg Tablet

Reference Listed Drug

Cozaar® 100 mg Tablets

Group Type: ACTIVE_COMPARATOR

Cozaar®

Intervention Type: DRUG

100 mg Tablet

Interventions

Losartan

100 mg Tablet

Intervention Type: DRUG

Cozaar®

100 mg Tablet

Intervention Type: DRUG

Other Intervention Names

Losartan (generic name)

Eligibility Criteria

Inclusion Criteria

• Non-child-bearing potential female or male.
• Non-smoker.
• 18 years of age and older.
• Capable of consent.
• Non-child-bearing potential female subject:

• Post-menopausal state: absence of menses for 12 months prior to drug administration.
• Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.

Exclusion Criteria

• Clinically significant illness within 4 weeks prior to the administration of the study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening.
• Positive testing for hepatitis B, hepatitis C, or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 100 bpm) at screening.
• Subjects with BMI > 30.0.
• History of significant alcohol abuse within 6 months prior to screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to the screening visit.
• History of allergic reactions to losartan or other related drugs.
• History of allergic reactions to heparin.
• Use of any drugs known to induce or inhibit drug metabolism within 30 days prior to administration of the study medication.
• Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowl diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the study drug.
• Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
• Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
• Positive alcohol breath test at screening.
• Subjects who have used tobacco in any form within 90 days preceding study drug administration.
• Any food allergy, intolerance, restriction, or special diet that could, in the opinion of the Medical Sub-Investigator, contraindicate the subjects participation in this study.
• A dept injection or an implant of any drug within 3 months prior to administration of study medication.
• Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:

• Less than 300 mL of whole blood within 30 days
• 300 mL to 500 mL of whole blood within 45 days, or
• more than 500 mL of whole blood within 56 days prior to drug administration.
• Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
• Clinically significant history of known active hypotension or volume depletion.
• Intolerance to venipuncture.
• Clinically significant history of renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
• Subjects unable to understand or unwilling to sign the Informed Consent Form.

• Breast-feeding subjects.
• Positive urine pregnancy test at screening (performed for all females).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Pharmaceuticals USA

Principal Investigators

Richard Larouche, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

Anapharm Inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

30272

Identifier Type: -

Identifier Source: org_study_id