Bioequivalence study of Ursodeoxycholic acid 300 mg capsules produced by Raha Pharmaceuticals Company

Bioequivalence study of Ursodeoxycholic acid (UDCA) Capsules manufactured by Raha Pharmaceutical Company with a brand Company

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231108059993N5

Enrollment

Registered

2025-06-04

Start date

2024-05-22

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

Bioequivalence study in healthy volunteers.

Interventions

Intervention 1: Single dose of ursodeoxycholic acid capsule 300mg from Dr. Falk Pharma GmbH as the reference product. Intervention 2: Intervention group: Single dose of ursodeoxycholic acid capsule 30

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

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 Contact?Saeed Ghanbarzadeh

Tabriz University of Medical Science

s_ghanbarzadeh@yahoo.com+98 21 3383 2649

Outcome results

None listed

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