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Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01124175
First received: May 13, 2010
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

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 fed conditions.


Condition Intervention Phase
Healthy
Drug: Losartan
Drug: Cozaar®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-way Crossover, Bioequivalence Study of Losartan 100 mg Tablets and Cozaar® Administered as 1 * 100 mg Tablet in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Losartan Cmax.

  • AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Losartan AUC0-t.

  • AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Losartan AUC0-inf.


Secondary Outcome Measures:
  • Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.

  • AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.

  • AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.


Enrollment: 80
Study Start Date: October 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Generic Test Product
Losartan 100 mg Tablets
Drug: Losartan
100 mg Tablets
Active Comparator: Reference Listed Drug
Cozaar® 100 mg Tablets
Drug: Cozaar®
100 mg Tablets
Other Name: Losartan (generic name)

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-child-bearing potential female or male.
  • Non-smoker
  • 18 years or 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.
  • ECG abnormalities (clinically significant) or vital sign abnormalities at screening.
  • Subjects with BMI greater than or equal to 30.0.
  • History of significant alcohol abuse within 6 months prior to the screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit equals 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
  • History of drug abuse of use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], or 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 of 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, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of 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 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 the 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 subject's participation in this study.
  • A depot 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 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 within 7 days prior to administration of the study medication.
  • Clinically significant history or known hypotension or volume depletion.
  • Intolerance to venipuncture.
  • Clinically significant history or renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
  • Subjects who are unable to understand or unwilling to sign the Informed Consent Form.
  • Additional exclusion criteria for females only:

    • Breast-feeding subjects.
    • Positive urine pregnancy test at screening (performed for all females).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124175

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Richard Larouche, MD Anapharm
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01124175     History of Changes
Other Study ID Numbers: 30273
Study First Received: May 13, 2010
Results First Received: June 21, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014