A bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting conditio
- Conditions
- Blood concentration of test and reference drug is compared.
- Registration Number
- IRCT20220209053979N2
- Lead Sponsor
- Alborz Darou
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Sex: male.Age: 18 - 55 years. . BMI of 18-27 kg/m2 with minimum of 50 kg weight.
Volunteer willing to adhere to the protocol requirements and to provide written informed consent
Non-smokers or smoker who smokes less than 10 cigarettes per day
Clinically relevant abnormalities in the results of the laboratory screening evaluation.
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
Pulse rate less than 50/minute or more than 100/minute.
History of allergy to the test drug or any drug chemically similar to the drug under investigation.
History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The plasma concentrations of the test and reference drugs is compared. A total of 16 blood samples are taken from each volunteer at different times. Timepoint: , 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration. Method of measurement: liquid chromatography mass spectrometry (LCMSMS).
- Secondary Outcome Measures
Name Time Method Plasma concentration of the drug and consequently y pharmacokinetic parameters such as maximum plasma concentration and area under curve of the concentration-time profile of test and reference drug. Timepoint: , 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 , 24 , 36 hours after drug administration. Method of measurement: Plasma concentration of the drug is analyzed by liquid chromatography with mass detector.