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A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

NCT03530228 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-05-21

No results posted yet for this study

Summary

A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects

Conditions

  • Pharmacodynamics
  • Pharmacokinetics
  • Healthy Male Volunteers

Interventions

DRUG

Tegoprazan (C1)

Tegoprazan QD, oral administration. Treatment A

DRUG

Tegoprazan (C1)

Tegoprazan QD, oral administration. Treatment B

DRUG

Treatment C: Tegoprazan (C1)

Tegoprazan BID, oral administration

DRUG

Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days. Group 1

DRUG

Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days. Group 2

DRUG

Esomeprazole (C2)

Esomeprazole QD, oral administration, for 7 days. Group 3

DRUG

Tegoprazan (C3)

Tegoprazan QD, oral administration

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2018-08-31
Completion
2018-08-31

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 NCT03530228 on ClinicalTrials.gov