]>
IRCT20200407046981N15 IRCT 2021-09-14 Daana pharmaceutical company Study of absorption and elimination rate of sitagliptin 50 mg tablets in comparison with standard tablets of Sitagliptin (Xelevia®). Comparative bioequivalence study of single oral dose of Sitagliptin 50 mg tablet produced by Daana pharmaceutical Co versus Xelevia® (Merck company) in 24 healthy males under fasting conditions 2021-10-22 anticipated 24 Complete https://irct.ir/trial/58372 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Individuals will be recruited voluntarily through advertising. 24 volunteers are randomly assigned to two sequences by lottery method. A table of random numbers from 1 to 24 is created and the table numbers are assigned to individuals in the order of entry of the candidates on the day of the test. At the moment of starting the study, candidates will receive reference medicine or test in two groups with numbers 1-12 and 13-24. Bioequivalence En In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Sitagliptin 50 mg of test and reference in healthy volunteers.. Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Sitagliptin 50 mg tablet produced by Daana Co. (Domestic). After the washout period, the volunteers are placed in the Intervention group 2. In fact, every single volunteers is used as control for himself. Intervention 2: Intervention group 2: In this group, volunteers are given a single oral dose of Sitagliptin 50 mg tablets (Xelevia), produced by Daana Company (Brand). After the washout period, the volunteers are placed in the Intervention group 1. In fact, every single volunteers is used as control for himself. 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 There is no further information
public Hamed Hamishehkar
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 3336 7914 Hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Jaber Emami
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7111 Emami@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The weight limit for each volunteer is between 60 and 100 kg. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. 18 years 55 years Male Known hypersensitivity or idiosyncratic reaction to Sitagliptin or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, volunteers are given a single oral dose of Sitagliptin 50 mg tablet produced by Daana Co. (Domestic). After the washout period, the volunteers are placed in the Intervention group 2. In fact, every single volunteers is used as control for himself. Intervention group 2: In this group, volunteers are given a single oral dose of Sitagliptin 50 mg tablets (Xelevia), produced by Daana Company (Brand). After the washout period, the volunteers are placed in the Intervention group 1. In fact, every single volunteers is used as control for himself. Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1، 2، 2.5، 3، 3.5، 4، 4.5، 5، 6، 8، 10، 12، 24 and 48 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS). AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 1، 2، 2.5، 3، 3.5، 4، 4.5، 5، 6، 8، 10، 12، 24 and 48 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS. Daana pharmaceutical company Approved 2021-08-23 Ethics committee of Tabriz University of Medical Science Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)