Study of absorption and elimination rate of Imatinib 100 mg capsules in comparison with standard tablet of Imatinib (Imatinib).

Not Applicable

Recruiting

Conditions: In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Imatinib capsules of test and reference in healthy volunteers..

Registration Number: IRCT20200407046981N4

Lead Sponsor: Kimia pharmaceutical Co

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 18

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

Known hypersensitivity or idiosyncratic reaction to Imatinib 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 & 72 hour after dosing. Method of measurement: high-performance liquid chromatography—mass spectrometry (HPLC-MS).

Secondary Outcome Measures

Name	Time	Method
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 SPSSIntervention groups.