Bioequivalence study of Tofacitinib 10 mg tablet

Bioequivalence study of Tofacitinib 10 mg tablet manufactured by Cobel daru versus originator brand in healthy volunteers in the fasted condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N79

Enrollment

Registered

2023-07-11

Start date

2023-06-22

Completion date

Unknown

Last updated

2023-07-25

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 1: single dose, one oral tablet 10 mg (Xeljanz) manufactured by Pfizer company, as a reference product. Intervention 2: Intervention group 2: Single dose, one oral A

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 alcohol and drug addiction history of allergy to Tofacitinib

Design outcomes

Primary

Measure	Time frame
The concentration of the drug in blood. Timepoint: Pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: Clock.;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

None listed

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