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IRCT20180620040164N76 IRCT 2025-01-08 Actover Pharmaceutical Co. Comparative in vivo evaluation of 2 Dapagliflozin/ Metformin 5/ 1000 mg Tablet and Xigdue® 5/ 1000 mg Tablet formulations. Comparative bioequivalence study of Dapagliflozin/ Metformin 5/ 1000 mg Tablet of ActoverCo. and Xigdue ® of Astera Zeneca as reference in 24 healthy male under fasting condition 2025-01-31 anticipated 24 Complete https://irct.ir/trial/81155 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 numbers (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 Diabetes mellitus due to underlying condition. Intervention 1: Intervention group 1: Dapagliflozin/ Metformin 5/ 1000 mg Tablet, produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention 2: Intervention group 2: Dapagliflozin/ Metformin 5/ 1000 mg Tablet (Xigdue®), produced by Astera Zeneca is the reference product. In each period, 12 of 24 subjects will be given a 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 undetermind yet.
public Behzad Montaha sangari
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 mforoutan@gmail.com Noor Research & Development Institute Iran (Islamic Republic of) Healthy subjects (male) between 20 – 45 years of age. 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 abnormal findings during laboratory evaluations and clinical examination.Subjects with normal vital signs. Candidates must have normal vital signs. The consent of the candidates to all the requirements of the clinical study based on the instructions of the clinical study, which has been confirmed by accepting the informed consent form. 20 years 45 years Male Sensitivity to the pharmaceutical substance being studied. Cardiovascular, pulmonary, acute or chronic hormonal nervous system disease, gastrointestinal disease, and visual impairments on ophthalmology examinations. A history of mental illness, water loss due to diarrhea or vomiting that lasts 24 hours before the medication is given. Systolic blood pressure greater than 130 or less than 100 mmHg. Diastolic blood pressure greater than 85 or less than 60 mmHg. Smokers who smoke more than 10 cigarettes a day and have problems with not smoking during each clinical study period. People who have used over the counter or doctor-prescribed medications 14 days before the start of the first period will need to take the medication at the same time during the study. People who have a history of alcoholism or alcohol consumption within the past 2 years. Volunteers who are heavy drinkers of caffeinated beverages, fruit juices (grapefruit juice) or follow a special diet (vegetarianism) or do heavy physical activity. A history of difficulty donating blood or donating more than 500 mL of blood less than seven days before the start of the study. E08 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs Intervention group 1: Dapagliflozin/ Metformin 5/ 1000 mg Tablet, produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group 2: Dapagliflozin/ Metformin 5/ 1000 mg Tablet (Xigdue®), produced by Astera Zeneca is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 11, 24 and 48 hours 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 will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 11, 24 and 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). Actover Pharmaceutical Co. Approved 2024-12-30 Research Ethics committees of school of pharmacy and nursing Midwifery-Shahid Beheshti University of Niayesh Highway, Valiasr Ave Tehran Tehran Iran (Islamic Republic of)