NCT01124175CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Teva Pharmaceuticals USA
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Study Overview
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 fed conditions.
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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).
Arms & Interventions
Generic Test Product
Experimental
Losartan 100 mg Tablets
Intervention: Losartan (Drug)
Reference Listed Drug
Active Comparator
Cozaar® 100 mg Tablets
Intervention: Cozaar® (Drug)
Outcomes
Primary Outcomes
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.
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.
Bioequivalence based on Losartan AUC0-inf.
Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)
Time Frame: Blood samples collected over a 24 hour period.
Bioequivalence based on Losartan Cmax.
Secondary Outcomes
- Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)(Blood samples collected over a 24 hour period.)
- AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)(Blood samples collected over a 24 hour period.)
- AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)(Blood samples collected over a 24 hour period.)
Investigators
Study Sites (1)
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