In this study, the disease is not examined. The subject of the study is the bioequivalence study of the sorafenib tablet of test and reference in healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group (Test): Sorafenib 200 mg tablet, produced by Kimia pharmaceutical Co. is the test product. In each period, 9 of 18 subjects will be given single oral dose of this pr
Sponsors
Kimia pharmaceutical Co
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The weight limit for each volunteer is between 60 and 100 kg. Only non-smokers are allowed to participate. They must be healthy in terms of liver and kidney status, respiratory system, and other general health characteristics that will be assessed.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Sorafenib or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48 & 72 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: During 2 months after intervention. 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