Bioequivalence investigation of the generic Karen Pharma and Food Supplement Co. Valsartan 160 mg tablet with brand Diovan® 160 mg tablet Novartis pharmaceuticals...
Conditions
Interventions
Intervention 1: Intervention group: (test): Valsartan 160 mg Tablet, produced by Karen Pharma and Food Supplement Co. is the test product. In each period, 12 of 24 subjects will be given single oral d
Sponsors
Karen Pharma and Food Supplement Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy candidates should be between 18-40 years old and their BMI should be in the range (Kg/m2) 18.5-30. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects must have normal vital signs. Sitting systolic blood pressure is in the range of 110-120 mm Hg and diastolic blood pressure is in the range of 70-80 mm Hg and heart rate is 60-90 beats per minute. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: History of known allergies to valsartan, new drugs or any of the inactive components of the formulation; A history of liver or gastrointestinal disease that may interfere with the absorption, distribution, metabolism, or excretion of the drug; History of liver or kidney disease Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study period. History of anaphylaxis or angioedema History of bleeding or coagulation problems People who have taken over-the-counter or prescription drugs 7 days before the start of the first period will need to take the drug at the same time during the study. People with a history of alcohol or drug addiction Subjects who consume heavy caffeinated beverages, fruit juices (grapefruit juice) either follow a special diet (vegetarian) or do strenuous physical activity. History of difficulty donating blood or donating more than 500 ml of blood in less than seven days before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: During 2 months 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: During 2 months 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