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IRCT20190706044111N10 IRCT 2019-09-15 Aburaihan Pharm Co. Bioequivalence study of Dexamethasone 4mg tablet of Abureihan Pharm Co., IRAN A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Dexamethasone 4mg tablet of Abureihan Pharm Co., IRAN in comparison of Dexamethasone 4mg tablet of GALEN in 24 healthy adult subjects under fasting condition 2019-11-22 anticipated 24 Complete https://irct.ir/trial/41339 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence Inflammatory diseases. Intervention 1: Intervention group:Single dose of Dexamethasone 4mg tablet of Abureyhan Pharm Co.,. Intervention 2: Control group: Single dose of Dexamethasone 4mg tablet of GALEN. 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 Publication of data & results is under permission of Abureihan Pharm. Co.
public Ladan Tayebi
1st floor, Saeidi Dd end, Felestin Ave.
Tehran Iran (Islamic Republic of) کدپستی: 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) کدپستی: 1416673971 +98 21 8895 6061 l.tayebi@parsbiopharmacy.com Pars Biopharmacy Research Co. Iran (Islamic Republic of) Aged between 20 - 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 showed clinically relevant deviations from normal in physical examination. 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 8 weeks 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. Other Other Intervention group:Single dose of Dexamethasone 4mg tablet of Abureyhan Pharm Co., Control group: Single dose of Dexamethasone 4mg tablet of GALEN Plasma concentration of dexamethasone. Timepoint: Plasma related to 0, 20, 40 min., 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 10 hr. after dosing. Method of measurement: HPLC. Aburaihan Pharm Co. Approved 2019-07-28 Ethics committee of Zahedan University of medical Sciences Dr. Hessabi square Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)