Bioequivalence Evaluation of Losartan and Cozaar® formulations in healthy volunteers
- Conditions
- Pharmacokinetics, Losartan , Bioequivalent.
- Registration Number
- IRCT20130603013572N5
- Lead Sponsor
- Daana pharma.Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
in healthy male and female volunteers
History of hypersensitivity to the study drug or related products.
Significant history or presence of gastrointestinal, kidney disease or any otherconditions known to interfere with the absorption, distribution, metabolism orexcretion of common medications.
Significant history of asthma, chronic bronchitis or other bronchospasticcondition.
Significant history or presence of glaucoma, cardiovascular or hematologicaldisease.
Any clinically significant illness during the 4 weeks prior to day of this study.
Maintenance therapy with any drug, or history of drug dependency, alcoholabuse, or serious neurological or psychological disease.
Participation in a clinical trial with an investigation drug within 30 dayspreceding day 1 of this study.
Use of enzyme- modifying drugs within 30 days prior to day 1 of this study.
Use of any systemic medication (including OTC preparations) within 14 daysprior day 1 of this study.
HIV and Hepatitis B and anti HCV antibody positive subjects.
Smoking
History of difficulty in donating blood
Donation of blood within 90 days before first dosing.
History of vaccination within one month before first dosing.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of drug concentration in blood plasma. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after drug administration. Method of measurement: blood samples collection.
- Secondary Outcome Measures
Name Time Method Time to peak plasma concentration. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: observational.;Maximum plasma concentration. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: observational.;Area under the plasma concentration–time curves. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: linear trapezoidal method.