Bioequivalence study of Sunitinib 50mg capsule

Bioequivalence study of Sunitinib 50 mg capsule manufactured by Zistdaru Danesh (Sunixha) versus Sutent 50 mg in healthy volunteers in the fasted condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N75

Enrollment

Registered

2023-05-02

Start date

2023-04-21

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: single dose, one oral capsule 50mg(Sutent) manufactured by Pfizer, as a reference product. Intervention 2: Intervention group: Single dose, one oral Sunixha 50 mg c

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 Sunitinib

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9,10,11, 12, 24, 48, 72h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time 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 ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results