Essential (primary) hypertension. Essential (primary) hypertension
Conditions
Interventions
Intervention 1: Intervention group 1: Hydrochlorothiazide 50 mg Tablet , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After
Sponsors
Karen Pharma and Food Supplement Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention.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
| Measure | Time frame |
|---|---|
| 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 Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention.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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed