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IRCT20130313012810N5 IRCT 2022-12-25 KIMIA Noavaran Daroui Comparative bioequivalence study of the Dapagliflozin 10-mg tablets manufactured by Noavaran Daroui Kimia Company Comparative bioequivalence study of the Dapagliflozin 10-mg tablets manufactured by Noavaran Daroui Kimia Company 2022-12-25 anticipated 24 Complete https://irct.ir/trial/67498 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence -. Intervention group: This study examines the bioequivalence of dapagliflozin produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control group. The intervention group, which includes healthy and fasting male volunteers, will receive a single dose of 10 mg tablets manufactured by Noavaran Daroui Kimia pharmaceutical company or AstraZeneca brand in two 48-hour periods, on the first day of each period. And in 15 different time periods up to 48 hours after taking the drug, blood samples will be taken from the volunteers in the amount of 3 ml each time, that is, a total of 45 ml within 48 hours. The training that will be given to the volunteers includes avoiding the consumption of drinks containing alcohol and xanthine and other interfering drugs in the prescription drug from 48 hours before the start of the study until the end of the study. Also, on the first day of the study, after receiving the drug, the volunteers received a 20% glucose solution, so that after taking the pill, they will immediately take 240 cc of glucose solution, and after that, they should drink 60 cc of glucose solution every 15 minutes for 4 hours.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Industry license will be required.
public Hamed Hamishehkar
Daneshgah St. Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3311 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 1336 3311 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The weight range of participating candidates must be between 60-100 kg. All candidates must be non-smokers. The candidates must be healthy in terms of physical examination, ECG and the following laboratory tests: hemoglobin, hematocrit, red and white blood count, MCV ( mean body mass), MCH (mean body hemoglobin), routine urinalysis, total cholesterol, triglycerides, total proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (γ-GT), amino aspartate transferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose. Volunteers who agreed to the informed consent form. 18 years 60 years Male History of allergic or adverse reaction to dapagliflozin or any similar product. Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg. Smokers. People who 10 days before the first day of consumption, Drug-experienced Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s). - - N/A Intervention group: This study examines the bioequivalence of dapagliflozin produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control group. The intervention group, which includes healthy and fasting male volunteers, will receive a single dose of 10 mg tablets manufactured by Noavaran Daroui Kimia pharmaceutical company or AstraZeneca brand in two 48-hour periods, on the first day of each period. And in 15 different time periods up to 48 hours after taking the drug, blood samples will be taken from the volunteers in the amount of 3 ml each time, that is, a total of 45 ml within 48 hours. The training that will be given to the volunteers includes avoiding the consumption of drinks containing alcohol and xanthine and other interfering drugs in the prescription drug from 48 hours before the start of the study until the end of the study. Also, on the first day of the study, after receiving the drug, the volunteers received a 20% glucose solution, so that after taking the pill, they will immediately take 240 cc of glucose solution, and after that, they should drink 60 cc of glucose solution every 15 minutes for 4 hours. Plasma concentration of the drug. Timepoint: 15 sampling time till 48 h. Method of measurement: LCMSMS. KIMIA Noavaran Daroui Approved 2022-09-19 Ethics committee of Tabriz University of Medical Sciences Daneshghah St. Drug Applied Research Center Tabriz East Azarbaijan Iran (Islamic Republic of)