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..
Conditions
Interventions
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
Sponsors
Daana pharmaceutical company
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Hamishehkar
Tabriz University of Medical Sciences
Outcome results
None listed