Bioequivalence study of Tacrolimus 1mg

Bioequivalence study of Tacrolimus 1mg ( Taclirus) manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N10

Enrollment

Registered

2021-11-18

Start date

2021-12-22

Completion date

Unknown

Last updated

2024-07-22

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, 3 oral capsules 1mg (Prograf) manufactured by Astellas, as a reference product. Intervention 2: Intervention group: Single dose, 3 oral capsules 1mg (T

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 Alcoholism and Narcoticism History of allergy to Tacrolimus

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0; 0.33; 0.66; 1; 1.33;01.66; 2; 2.5; 3; 3.5; 4; 5; 6; 8; 10; 12; 24; 48; 72h after drug administration. Method of measurement: LC -MASS-MASS.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

Ghasemian_elham@yahoo.com+98 21 4163 7000

Outcome results

None listed

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