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PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

NCT06332638 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-27

No results posted yet for this study

Summary

The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily.

Conditions

  • Healthy

Interventions

DRUG

Tegoprazan 12.5mg

Oral administration of one tablet of Tegoprazan 12.5mg twice daily for 14 days.

DRUG

Tegoprazan 25mg

Oral administration of one tablet of Tegoprazan 25mg once daily for 14 days.

DRUG

Famotidine 20mg

Oral administration of one tablet of Famotidine 20mg twice daily for 14 days.

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Jong Lyul Ghim, MD, PhD · Department of Clinical Pharmacology, Inje University Busan Paik Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2024-07-31
Completion
2024-07-31

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 NCT06332638 on ClinicalTrials.gov