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In vivo bioequivalence study of Imatinib 100 mg capsule

Fasted state in vivo bioequivalence study for Imatinib 100 mg capsule manufactured by Avicenna Co. in comparison to German brand AQVIDA

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210519051345N6
Enrollment
24
Registered
2021-11-14
Start date
2021-11-06
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Fasted state in vivo bioequivalence study.

Interventions

Intervention 1: Intervention group: In this group, a single dose of 100 mg imatinib capsule made by Avicenna company is taken orally and then after a washout period of one week, a 100 mg imatinib c

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: General Health including Liver, Heart and Kidney health Being at the age of 25-55 years old

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

MeasureTime frame
Drug Plasma Concentration. Timepoint: Blood samples will be obtained prior to dosing (baseline) and 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 3.5, 4.0; 4.5, 6.0; 8.0; 12.0; 24.0; 48.0 and 72.0 h post-dose. Method of measurement: High performance liquid chromatography (HPLC).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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