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Bioequivalence study of Dasatinib 50 mg tablet

Bioequivalence study of Dasatinib 50mg tablet manufactured by Zistdaru Danesh versus Sprycel 50 mg in healthy volunteers in the fed and fasted condition

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200623047902N22
Enrollment
48
Registered
2022-12-29
Start date
2023-01-05
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: single dose, one oral tablet 50mg(Sprycel) manufactured by Bristol-mayer, as a reference product. Intervention 2: Intervention group: Single dose, one oral Dasaxha

Sponsors

Zistdaru danesh Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Drug plasma concentration. Timepoint: Immediately before and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.

Secondary

MeasureTime frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Zistdaru danesh Co.

ghasemian@zistdaru.ir+98 21 6696 5196

Outcome results

None listed

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