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IRCT20230222057495N3 IRCT 2023-04-03 Yab Daro Company Bioequivalence study of empagliflozin 10 mg tablet The bioequivalence study of empagliflozin 10 mg tablets of Daram Yab Darou pharmaceutical company compared to the sample of empagliflozin 10 mg manufactured by Boehringer Ingelheim and Eli Lilly, Germany, on healthy volunteers. 2023-04-04 anticipated 24 Complete https://irct.ir/trial/69065 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence In the present study, no disease was investigated.. The study consists of two phases (taking one empegliflozin 10 mg tablet orally at each study time, for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Each phase lasts 48 hours. You must fast for 10 hours before the start of each phase. On the morning of the study, you must be present at the place of the study at 7:00 a.m. to have an angiocat installed on your arm and for 12 hours. It will remain on your hand. In order to continue sampling, without the need for the volunteer's permanent presence, and by referring to the mentioned time intervals, it is done by syringe. 5 ml of blood before drug administration and at sampling times based on hours, 15 time points including: 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 And 48 will be taken from you (15 times in total). To prevent hypoglycemia, the drug is prescribed with 240 ml of glucose 20 solution in water, and then 60 ml of glucose solution every 15 minutes to 4 hours after the dose. With a gap of one week after receiving the first drug, the candidates must go to receive another drug and all these steps will be repeated. The total duration of participation of the candidates in both stages of this study will be a total of 96 hours, the candidates will be covered by Pasargad insurance for the entire duration of this study, and all stages of this study will be commissioned and sponsored by Darman Yab Darou pharmaceutical company (as the employer in this study) are In the first stage of the study, you will be randomly assigned to one of the following two groups: group one formula A (Jardiance® brand produced by the foreign company Boehringer Ingelheim and Eli Lilly, Germany) and group two formula B (generic Empagliflozin by the domestic company Darman Pharmaceutical Company the drug tracer has been produced) consumes Formulas A and B are products in the form of 10 mg tablets.. 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 There is no further information
public Monireh Jalalipour
No. 4, Imam Khomeini Boulevard, Azadegan Square
Mahdasht Karaj Iran (Islamic Republic of) 3188913179 +98 26 3731 8748 info@naplab.ir Nik Azma Pars Alborz laboratory scientific Monireh Jalalipour
No. 419, Imam Khomeini Boulevard, Azadegan Square
Mahdasht Karaj Iran (Islamic Republic of) 3188913179 +98 26 3731 8748 info@naplab.ir Nik Azma Pars Alborz laboratory Iran (Islamic Republic of) Be between 18 and 50 years old. All candidates must be non-smokers. The Volunteer's body mass index (BMI) should be less than 30 kg for the square of their height in meters. 18 years 50 years Both Volunteers with blood pressure less than 90/60 mm Hg or higher than 140/90 mm Hg. Volunteers should refrain from smoking, consuming alcohol, caffeine (including coffee, cocoa, tea, cola drinks) 48 hours before the start of the study. Other The study consists of two phases (taking one empegliflozin 10 mg tablet orally at each study time, for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Each phase lasts 48 hours. You must fast for 10 hours before the start of each phase. On the morning of the study, you must be present at the place of the study at 7:00 a.m. to have an angiocat installed on your arm and for 12 hours. It will remain on your hand. In order to continue sampling, without the need for the volunteer's permanent presence, and by referring to the mentioned time intervals, it is done by syringe. 5 ml of blood before drug administration and at sampling times based on hours, 15 time points including: 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 And 48 will be taken from you (15 times in total). To prevent hypoglycemia, the drug is prescribed with 240 ml of glucose 20 solution in water, and then 60 ml of glucose solution every 15 minutes to 4 hours after the dose. With a gap of one week after receiving the first drug, the candidates must go to receive another drug and all these steps will be repeated. The total duration of participation of the candidates in both stages of this study will be a total of 96 hours, the candidates will be covered by Pasargad insurance for the entire duration of this study, and all stages of this study will be commissioned and sponsored by Darman Yab Darou pharmaceutical company (as the employer in this study) are In the first stage of the study, you will be randomly assigned to one of the following two groups: group one formula A (Jardiance® brand produced by the foreign company Boehringer Ingelheim and Eli Lilly, Germany) and group two formula B (generic Empagliflozin by the domestic company Darman Pharmaceutical Company the drug tracer has been produced) consumes Formulas A and B are products in the form of 10 mg tablets. Empagliflozin plasma concentrations. Timepoint: 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours. Method of measurement: HPLC-MS/MS. Yab Daro Company Approved 2023-03-07 Ethics Committee of Tehran University of Medical Sciences Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Porsina Street Tehran Tehran Iran (Islamic Republic of)