Comparative in vivo evaluation of 2 Amlodipine 10/Valsartan160 mg Tablet formulations.
- Conditions
- Essential (primary) hypertension.Essential (primary) hypertension
- Registration Number
- IRCT20180620040164N36
- Lead Sponsor
- Karen Pharma and Food Supplement Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range (kg/m2) 18.5 and 30.
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 who agree with patient consent form.
Subjects with known allergy to the products tested.
Acute infection within one week preceding first study drug administration.
Hypotension (systolic blood pressure =100 mmHg or diastolic blood pressure =65 mmHg) or hypertension (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg)
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period;
Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period;
History of alcohol or drug abuse;
Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity;
A history of difficulty with donating blood or 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: Before intervention and then at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48 and 72 hours post intervention in each period. 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: Before intervention and then at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48 & 72 hours post intervention in each period. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).