Bioequivalence study of 300 mg ursodeoxycholic acid capsules

Bioequivalence study of 300 mg ursodeoxycholic acid capsule of Kimidaro Pharmaceutical Company compared to 300 mg ursodeoxycholic acid of Aurobindo Pharma LTD, India on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N5

Enrollment

Registered

2023-06-05

Start date

2023-05-22

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

In the present study, no disease was investigated..

Interventions

Intervention 1: Intervention group 1: includes the oral consumption of two 300 mg ursodeoxycholic acid capsules manufactured by Kimidarou Pharmaceutical Company of Iran on 24 healthy fasting volunteer

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers between the ages of 18 and 50 All candidates must be non-smokers Body mass index less than 30 kg per square meter

Exclusion criteria

Exclusion criteria: Blood pressure less than 90 over 60 mm Hg or more than 140 over 90 mm Hg Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration of ursodeoxycholic acid. Timepoint: 1,0.5 hours before and 0, 0.5, , 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration. Method of measurement: Liquid chromatography–mass spectrometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results

None listed

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