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IRCT20190706044111N33 IRCT 2023-07-01 Vitabiotix Pharmed Bioequivalence study of GLICLAVITE 60mg tablet of Vitabiotics Pharmed Co., IRAN A randomized, open label, single dose, crossover, bioequivalence study of GLICLAVITE 60mg tablet of Vitabiotics Pharmed Co., IRAN in comparison of DIAMICRON MR 60mg tablet of Servier in 24 healthy adult subjects under fasting condition 2023-09-23 anticipated 24 Complete https://irct.ir/trial/70912 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: Using Excel software, each subject will be randomly assigned to one of the two sequence AB or BA in a balanced manner. Bioequivalence Diabetes. Intervention 1: Intervention group: GLICLAVITE 60mg tablet of Vitabiotics Pharmed Co., (IRAN), single dose, cross over. Intervention 2: Control group: DIAMICRON MR 60mg, produced by Servier company, single dose, cross over. 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 Any publication is under permission of Vitabiotics Pharmed Co.
public Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. scientific Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. Iran (Islamic Republic of) Aged between 18 - 50 years Body weight between 50 – 100 kg Having good health on the basis of medical history and physical & clinical examination Understand the procedures and give written informed consent 18 years 50 years Both Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment Subject had a history of drug or alcohol abuse Subject who smokes more than 10 cigarettes per day Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment Z79. 84 Long term (current) use of oral hypoglycemic drugs Other Other Intervention group: GLICLAVITE 60mg tablet of Vitabiotics Pharmed Co., (IRAN), single dose, cross over. Control group: DIAMICRON MR 60mg, produced by Servier company, single dose, cross over. Plasma concentration of gliclazide. Timepoint: at 0 (before dosing), 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 24.0, 48.0 & 72.0 hr. after dosing. Method of measurement: Using High Performance Liquid Chromatography wit UV detector (HPLC/UV). Vitabiotix Pharmed Approved 2023-05-14 Ethics committee of Zahedan University of medical Sciences 2nd Floor, Central Headquarters Building, University of Medical Sciences Campus, Dr. Hasabi Square, Gulf of Fars Blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)