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IRCT20180620040164N28 IRCT 2022-06-08 Cosar pharmaceutical Co. Clinical study to compare the in vivo parameters of 2 Tamsulosin 0.4 mg ER Capsule formulations Comparative bioequivalence study of Tamsulosin 0.4 mg ER Capsule of Cosar Pharmaceutical Co. and ّ Omnic of astellas in 24 healthy male under fasting. 2022-06-14 anticipated 24 Complete https://irct.ir/trial/63850 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The Block randomization was done at the site: https://www.sealedenvelope.com/simple-randomiser/v1/lists. By the aid of this method, all possible assignments within a block is calculated. Then, the blocks are randomly chosen to assign the subject numbers into groups with equal sample size. The numbers are assigned to subjects according to the subjects' study entrance order during screening period. The groups include 2 Test/Reference or Reference/Test sequence of drug administration with non-blinded allocation. Bioequivalence . Intervention 1: Intervention group: Tamsulosin 0.4 mg Capsule, produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.After 7-day wash-out period the control intervention will be given to these subjects. Intervention 2: Control group: Omnic 0.4 mg Capsule, produced by astellas is the refrence product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the test intervention will be given to these subjects. No - There is not a plan to make this available Justification or reason for not sharing IPD is It's undetermind yet.
public Ali Aghaei
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, 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 Street, Hosseini Square, Teymoury Street, Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Tavan Institute Iran (Islamic Republic of) Healthy Subjects should be between 20-45 years old. Body Mass Index (BMI) within 15% of normal range 18.5 and 30 (inclusive), calculated as kg/m2. 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. Subjects agree to all clinical study requirements based on clinical study guidelines that have been approved by accepting the informed consent form. 18 years 45 years Male History of known allergies to test products. Subject with a history of neoplastic disease (cancer), stroke, chronic seizures or major neurological disorder, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study 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. People who have a history of alcoholism or alcohol consumption in the past 2 years. Heavy drinker of caffeine, grapefruit juice or caffeinated drinks.who are on special diet (such as vegetarians). Who 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: Tamsulosin 0.4 mg Capsule, produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.After 7-day wash-out period the control intervention will be given to these subjects. Control group: Omnic 0.4 mg Capsule, produced by astellas is the refrence product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the test intervention will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples up to 48 hours and sample analysis during 3 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: 14 blood samples up to 48 hours and sample analysis during 3 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). Cosar pharmaceutical Co. Approved 2022-05-24 Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medica Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)