Investigating the in vivo bioequivalence of Ursodeoxycholic acid 300 mg capsule

Bioequivalence study of Ursodeoxycholic acid 300mg capsule manufactured by Hakim Co. compared with innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N25

Enrollment

Registered

2023-02-08

Start date

2023-02-24

Completion date

Unknown

Last updated

2023-03-13

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: Intervention group will receive a single oral dose of test product (Ursodeoxy cholic acid 300 mg capsule manufactured by Hakim Co.) in fasted st

Eligibility

Sex/Gender

Male

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease, liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: At intervals between half and 72 hours after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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