Study of absorption and elimination rate of Imatinib 400 mg capsules in comparison with standard tablet of Imatinib (Gleveec).

Randomized, single-dose, crossover comparative bioequivalence study of the Imatinib 400 mg capsules produced by Kimia pharmaceutical Co versus Gleveec® (NOVARTIS company) in 30 healthy males under fasting conditions

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200407046981N9

Enrollment

Registered

2021-05-01

Start date

2021-04-25

Completion date

Unknown

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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..

Interventions

Intervention 1: Intervention group (Test): Imatinib 400 mg capsule, produced by Kimia pharmaceutical Co. is the test product. In each period, 15 of 30 subjects will be given single oral dose of this p

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, kidney, respiratory system, mental and other general health characteristics that will be assessed.

Exclusion criteria

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 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), AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 1? 1.5? 2? 2.5? 3? 4? 6? 8? 12? 24? 48? 72 and 96 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS) and using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups.	—

Measure

Time frame

Peak Plasma Concentration (Cmax), AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before dosing), 1? 1.5? 2? 2.5? 3? 4? 6? 8? 12? 24? 48? 72 and 96 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS) and using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Hamishehkar

Tabriz University of Medical Sciences

Hamishehkar.hamed@gmail.com+98 41 3336 7914

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026