Bioequivalence study

Comparative Bioequivalence Study of the Ursodeoxycholic acid 250-mg/5 ml Suspension Produced by Raha Pharmaceutical Co.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231108059993N4

Enrollment

Registered

2025-05-29

Start date

2025-05-16

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

The study uses healthy men volunteers aged 18-60..

Interventions

Intervention 1: Control group:The control group in this study is to investigate the bioequivalence of Ursodeoxycholic acid 250-mg/5 ml Suspension Produced by Raha Pharmaceutical Co. Intervention 2: Co

Eligibility

Sex/Gender

Male

Age

18 Days to 60 Days

Inclusion criteria

Inclusion criteria: Have good general health (liver, heart, and kidneys). Body mass index is (18-28). Informed consent will be obtained. Ages are (18-60 years).

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease Pregnancy Alcohol and drug addiction History of allergy to this drug

Design outcomes

Primary

Measure	Time frame
Drug concentration. Timepoint: 16 sampling time included pre-dose (time 0) and at the following hours post-dose: 0/5, 1, 1/5, 2, 2/5, 3, 4, 5, 6, 7, 8, 10,24,48 and 72 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzaeh

Tabriz University of Medical Sciences

payeshdarou@gmail.com0414173645

Outcome results

None listed

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