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IRCT20190706044111N4 IRCT 2019-08-25 Alborzdarou Pharm. Co. Bioequivalence study of Sitagliptin 50mg tablet of Alborzdarou Pharm Co., IRAN A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Sitagliptin 50mg tablet of Alborzdarou Pharm Co., IRAN and Januvia 50mg tablet of MSD in 24 healthy adult subjects under fasting condition 2019-06-20 anticipated 24 Complete https://irct.ir/trial/41517 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence . Intervention 1: Intervention group: Single oral dose of Sitagliptin 50mg * 2 tablets of Alborzdarou Pharm Co. Intervention 2: Control group: Single oral dose of Januvia 50mg * 2 tablets of MSD. 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 Albordarou 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 20 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 tree 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. Subject had a history of allergic to this class of drugs Other Other Intervention group: Single oral dose of Sitagliptin 50mg * 2 tablets of Alborzdarou Pharm Co. Control group: Single oral dose of Januvia 50mg * 2 tablets of MSD Plasma concentration of sitagliptine. Timepoint: 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0 & 36.0 hr. post dose. Method of measurement: HPLC. Alborzdarou Pharm. Co. Approved 2019-03-03 Ethicc committee of Shahid Beheshti University of Medical Sciences Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave Tehran Tehran Iran (Islamic Republic of)