Comparative in vivo evaluation of 2 Hydrochlorothiazide 50 mg Tablet formulations.
- Conditions
- Essential (primary) hypertension.Essential (primary) hypertension
- Registration Number
- IRCT20180620040164N51
- Lead Sponsor
- Karen Pharma and Food Supplement Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Healthy volunteers
Between 18 – 45 years of age and
Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects with normal vital signs.
Subjects with a history of known hypersensitivity to hydrochlorothiazide or other sulfonamide drugs, associated acute or chronic infections;
Volunteers who have water and electrolyte disorders, including low blood potassium and sodium, history of diarrhea or vomiting, headache, muscle cramps or weakness in the past two weeks;
blood pressure in standing position and after at least 5 minutes of rest, systole less than 100 or more than 140 mmHg and diastole less than 60 or more than 90 mmHg);
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period;
volunteers with a history of difficulty with donating blood;
donation of more than 500 ml blood within 7 days prior to the start of the study;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).