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

NCT04494269 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-11-09

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment
  • Healthy

Interventions

DRUG

Tegoprazan 50mg

Oral administration once daily

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Jung-Ryul Kim, MD, PhD · Samsung Medical Center

  • Yang-Won Min, MD, PhD · Samsung Medical Center

  • Dong-Seong Shin, MD, PhD · Gachon University Gil Medical Center

  • Eon-Hye Kim, MD, PhD · CHA Bundang Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494269 on ClinicalTrials.gov