]>
IRCT20130313012810N55 IRCT 2025-03-29 Noavaran Daroui Kimia Dapagliflozin/Metformin tablet bioequivalence Comparative bioequivalence study of the Dapagliflozin 10 mg/ Metformin HCl 500 mg Extended-release tablets manufactured by Noavaran Daroui Kimia Company vs Xigduo® tablets manufactured by AstraZeneca Pharmaceutical Company in healthy volunteers 2025-04-21 anticipated 24 Complete https://irct.ir/trial/82570 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, 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 the Dapagliflozin 10 mg/ Metformin 500 mg tablets manufactured by Noavaran Daroui Kimia Pharmaceutical Company. In each period, 12 of 24 subjects will be given single oral dose of this product. After the one week, 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 the Dapagliflozin 10 mg/ Metformin 500 mg tablets manufactured by AstraZeneca Pharmaceutical Company. In each period, 12 of 24 subjects will be given single oral dose of this product. After the one week, the volunteers are placed in the Intervention group 1. No - There is not a plan to make this available Justification or reason for not sharing IPD is Industry license will be required
public Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences, Daneshgah Street,Tabriz
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, Daneshgah Street,Tabriz
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 All candidates must be non-smokers 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 55 years Both History of allergic or adverse reaction to Dapagliflozin/Metformin or any similar product Volunteers with blood pressure less than 90/60 mm Hg or higher than 140/90 mm Hg Individuals who have donated whole blood during the last 2 months Individuals who have donated blood components, such as platelets, within the past 2 weeks Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, volunteers are given a single oral dose of the Dapagliflozin 10 mg/ Metformin 500 mg tablets manufactured by Noavaran Daroui Kimia Pharmaceutical Company. In each period, 12 of 24 subjects will be given single oral dose of this product. After the one week, the volunteers are placed in the Intervention group 2. Intervention group 2: In this group, volunteers are given a single oral dose of the Dapagliflozin 10 mg/ Metformin 500 mg tablets manufactured by AstraZeneca Pharmaceutical Company. In each period, 12 of 24 subjects will be given single oral dose of this product. After the one week, the volunteers are placed in the Intervention group 1. Plasma concentration of the drug. Timepoint: 13 sampling time included pre-dose (time 0) and at the following hours post-dose: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS). Noavaran Daroui Kimia Approved 2025-03-10 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)