In-vivo Bioequivalence Test of Dasatonib tablet 100 mg Abidi Pharma with brand drug (SPRYCEL® 100 mg FC Tab, Bristol-Myers Squibb, UK)

In- Vivo Bioequivalence study of Dasatonib tablet 100 mg Abidi Pharma (LARACEL® 100 mg Tab. Abidi Pharma, Iran) with brand drugs (SPRYCEL® 100 mg FC Tab, Bristol-Myers Squibb, UK) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N66

Enrollment

Registered

2022-08-31

Start date

2022-06-25

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group: One test tablet (Dasatonib tablet 100 mg Abidi Pharma ) will be received. Blood samples will be taken for 24 hours at the mentioned times after drug administration

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-60 years old

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0? 0.5? 1? 1.25? 1.5? 1.75? 2? 3? 4? 6? 10 .8? 12, 24 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDariush Omidfar

Simin Baspar Teyf Gostar Company

Dariush.omidfar@gmail.com+98 41 3384 2724

Outcome results

None listed

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