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IRCT20180620040164N45 IRCT 2023-05-09 Dorsa Pharmaceutical Co. Bioequivalence study of Sildenafil 100 mg tablet in 24 healthy male under fasting conditions Comparative bioequivalence study of Sildenafil 100 mg tablets of Dorsa Pharmaceutical Co. and Pfizer in 24 healthy male under fasting. 2022-11-07 anticipated 24 Complete https://irct.ir/trial/66371 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer's number (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer. Bioequivalence Bioequivalence investigation of the generic Dorsa Pharmaceutical Co. Sildenafil 100 mg Tablet with brand Viagra Pfizer Tablet.. 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 product. Intervention 2: Intervention group: (refrence): Viagra 100 mg Tablet, produced by Pfizer is the refrence product. In each period, 12 of 24 subjects will be given single oral dose of this product. No - There is not a plan to make this available Justification or reason for not sharing IPD is It's not specified yet
public Ali Aghaei
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Noor Research & Development Institute scientific Seyed Mohsen Foroutan
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Tavan Institute Iran (Islamic Republic of) 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. 20 years 45 years Male 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. Treatment - Drugs Treatment - Drugs 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 product. Intervention group: (refrence): Viagra 100 mg Tablet, produced by Pfizer is the refrence product. In each period, 12 of 24 subjects will be given single oral dose of this product. 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). 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). Dorsa Pharmaceutical Co. Approved 2021-08-10 Ethics committee of Shahid Beheshti University of Medical Sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)