A phase-I, open label, dose-escalation, safety, tolerability andpharmacokinetics study of Nor-ursodeoxycholic acid tablets 500 mg

Phase 1

Completed

• Conditions: Healthy Human Volunteers

• Registration Number: CTRI/2022/11/047561
• Lead Sponsor: Shilpa Medicare Limited

Brief Summary

This is a phase-I open label, dose-escalation, safety, tolerability and pharmacokinetics study.

Study Objectives:

01. To evaluate safety and tolerability of single ascending doses of Nor-ursodeoxycholic acid tablets (500 mg, 1000 mg & 1500 mg) in healthy adult human subjects.

02. To determine the pharmacokinetics of Nor-ursodeoxycholic after single dose oral administration.



Dose proportionality: Dose proportionality, after single dose oral administration Nor-ursodeoxycholic acid tablets at 500 mg to 1500 mg

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-25
• Study Completion: 2022-12-14
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of study drug-related DLTs (Safety) and assessment of tolerability after single dose administration at dose levels of 500mg and 1000mg and 1500 mg	A total of 34 venous blood samples will be collected in each Cohort. | Blood samples will be collected at -48.0, -42.0, -36.0, -30.0, -24.0, -18.0, | -12.0, -6.0, pre-dose (0.0) hours prior to dosing and at 0.083 (5 minute), | 0.167 (10 minute), 0.333 (20 minute), 0.5 (30 minute), 0.667, 0.833, 1.0, | 1.167, 1.334, 1.5, 1.667, 1.834, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, | 24.0, 36.0, 48.0 and 72.0 hours post dose.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters will be calculated on below	1. Pharmacokinetic parameters at dose level

Trial Locations

Locations (1)

Cliantha Research Limited; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research Limited

🇮🇳Ahmadabad, GUJARAT, India

Dr DHRUV PRAVINKUMAR PATEL

Principal investigator

9978336240

dppatel@cliantha.com