Bioequivalence study of Tacrolimus 1 mg capsule

In vivo fasted-state bioequivalence study of Tacrolimus 1 mg capsules manufactured by Sobhan oncology Pharmaceutical Co. compared to innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N54

Enrollment

Registered

2025-11-17

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

In the present study, the products will be administered to healthy volunteers.

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Tacrolimus 1 mg capsule manufactured by Sobhan Oncology, Iran) in fasted state. Samples will be

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney) Age (18-55 years)

Exclusion criteria

Exclusion criteria: Smoking History of drug allergy Pregnancy Alcohol and drug addiction

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: Before drug administration and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 and 72 hours after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Valizadeh

Tabriz University of Medical Sciences

valizadehh@gmail.com+98 41 3334 8801

Outcome results

None listed

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