Bio equivalence study of Hydrochlorothiazide 50 mg tablets
Not Applicable
- Conditions
- Bioequivalance Hydrochlorothiazide 50 mg.
- Registration Number
- IRCT20200513047423N4
- Lead Sponsor
- Fatak Chemie Pars
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy liver
Healthy Kidney
Observing BMI
Age range between 18 and 50 years
Male and female
Exclusion Criteria
Smoking
Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax): after drug administration, gradually the plasma concentrations increase to Cmax. After Cmax, the plasma concentrations decrease regarding to drug elimination phenomena. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.;Tmax: the time after drug administration take to reach drug plasma concentration to Cmax. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.;Area under curve (AUC): AUC is obtained by plotting the plasma concentrations against corresponding times. Timepoint: 0, 0.5, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after intervention. Method of measurement: High performance liquid chromatography.
- Secondary Outcome Measures
Name Time Method