Bioequivalence study of two 300 mg Ursodiol (Ucidrol®) capsule manufactured by Tadbir Kalaye Jam company

Bioequivalence study of two 300 mg Ursodiol (Ucidrol®) capsule manufactured by Tadbir Kalaye Jam company in comparison with URSODIOL® 300 mg Actigall company on healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240803062623N14

Enrollment

Registered

2025-07-04

Start date

2025-08-11

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..

Interventions

Intervention 1: Intervention group: Single-dose of the test drug 300 mg Ursodiol (Ucidrol®) capsule manufactured by Tadbir Kalaye Jam company. Intervention 2: Control group: Single-dose of the refere

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-30) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking history of cardiovascular disease history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: -48, -42, -36, -30, -24, -18, -12, -6 , 0 , 0.5, 0.67, 1 , 1.33, 1.66, 2 , 2.33, 2.66, 3 , 3.5, 4 , 5 , 6 , 8 , 10 , 12 , 24 , 48 , 72h after drug adminstration. Method of measurement: HPLC-MS/MS.	—

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 ContactMohammad Ali Karkhaneh Yousefi

Tadbir Kalaye Jam co.

yousefi@tadbirkala.com+98 21 8866 8700

Outcome results

None listed

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