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A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

Healthy Clinical Trial

Official title:
An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

Clinical Trial Summary

The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.

Clinical Trial Description

[Pharmacokinetic Assessment] - Measurements - Tegoprazan and desmethyl tegoprazan (M1) in blood and urine - Endpoints - Primary endpoints: AUClast and Cmax of tegoprazan and M1 - Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1 [Safety Assessment] - Adverse events (AEs) - Clinical laboratory tests - Vital sign - Physical examination - Electrocardiogram (ECG) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04494269
Study type Interventional
Source HK inno.N Corporation
Contact Youngshin Keum, R.Ph, Pharm.D
Phone +82-2-6477-0204
Email ys.keum@inno-n.com
Status Recruiting
Phase Phase 1
Start date September 8, 2020
Completion date December 2023
View Details
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