Design, production, and comparison of serum level of Ursodeoxycholic acid Nanoemulsion with its capsule form in infants under 5 years with cholestasis

Not Applicable

• Conditions: CHOLESTASIS.; Toxic liver disease with cholestasis; K71.0

• Registration Number: IRCT20210306050598N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 May 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Infants under 5 years with cholestasis

Exclusion Criteria

Infants with noncompliant parents about blood sampling.
Patients who are older than 5 year
Infants with presurgery cholestasis.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum concentration of Ursodeoxycholic acid. Timepoint: 0-1-3-5-12 and 24 hr after drug administration. Method of measurement: The blood samples taken from the study group were collected in heparinized tubes and after plasma separation, the plasma was frozen at a temperature of minus 20 ° C and the samples were stored. Samples will analyze by GC-Mass after one day. Calculation of pharmacokinetic factors, Cmax, AUC, Tmax is performed using GC-Mass analysis.

Secondary Outcome Measures

Name	Time	Method
Serum concentration of Ursodeoxycholic acid. Timepoint: 0-1-3-5-12-24 h after drug administration. Method of measurement: The blood samples taken from the study group were collected in heparinized tubes and after plasma separation, the plasma was frozen at a temperature of minus 20 ° C and the samples were stored. Samples are analyzed by GC-Mass after one day.