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IRCT20130313012810N17 IRCT 2023-11-08 Rayhaneh Pharmaceutical Company Comparative bioequivalence study of the Empagliflozin 25-mg Tablets manufactured by Rayhaneh Pharmaceutical Company Comparative bioequivalence study of the Empagliflozin 25-mg Tablets manufactured by Rayhaneh Pharmaceutical Company 2023-11-16 anticipated 24 Complete https://irct.ir/trial/73600 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period. Bioequivalence Bioequivalence study in healthy volunteers. Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Empagliflozin tablet 25 mg produced by Rayhaneh Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2. Intervention 2: Intervention group 2: In this group, volunteers are given a single oral dose of Empagliflozin tablet 25 mg (Jardiance®), produced by Boehringer Ingelheim Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1. 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
Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 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 3336 3181 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The weight range of participating candidates should be between 60-100 kg Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (γ-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose Volunteers who have agreed to an informed consent form All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw 18 years 60 years Both History of allergic or adverse reaction to Azithromycin or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Smokers 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 N/A Intervention group 1: In this group, volunteers are given a single oral dose of Empagliflozin tablet 25 mg produced by Rayhaneh Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2. Intervention group 2: In this group, volunteers are given a single oral dose of Empagliflozin tablet 25 mg (Jardiance®), produced by Boehringer Ingelheim Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1. Plasma concentration of the drug. Timepoint: 15 sampling time included pre-dose (time 0) and at the following hours post-dose: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, and 48 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). Rayhaneh Pharmaceutical Company Approved 2023-10-16 Ethics committee of Tabriz University of Medical Sciences Daneshghah St. Drug Applied Research Center Tabriz East Azarbaijan Iran (Islamic Republic of)