Essential (primary) hypertension. Essential (primary) hypertension
Conditions
Interventions
Intervention 1: Intervention group 1: Amlodipine 10 mg + Valsartan 160 mg tablet, produced by Karen is the test product. In each period, 12 of 24 subjects will be given single oral dose of this produc
Sponsors
Karen Pharma and Food Supplement Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed