Bioequivalence investigation of the generic Dorsa Pharmaceutical Co. Sildenafil 100 mg Tablet with brand Viagra Pfizer Tablet..
Conditions
Interventions
Intervention 1: Intervention group:(test):Sildenafil 100 mg Tablet, produced by Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this p
Sponsors
Dorsa Pharmaceutical 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 according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings in laboratory evaluations. Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Allergic reaction to sildenafil Acute or chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, and also diseases of the gastrointestinal tract, liver, kidneys and blood, eye disease The presence of mental disorders, including a history. Dehydration due to diarrhea, vomiting or other reason within the last 24 hours before taking the drug Consumption of nitric oxide donor drugs, organic nitrates or other nitrite forms during the 30 days before drug administration in study period I. Systolic blood pressure (SBP) <100 mm Hg or = 130 mm Hg Diastolic blood pressure (DBP) <60 mm Hg or = 85 mm Hg. 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 1 days prior to the start of the study and might need drug intake during study period; History of alcohol or drug abuse within 2 years before the start of the study; 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: 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