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PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers

NCT05723510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-12-11

No results posted yet for this study

Summary

This study aims to evaluate the effects of combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults.

Conditions

  • Healthy

Interventions

DRUG

Tegoprazan 50mg

Oral administration of one tablet of tegoprazan 50 mg once daily

DRUG

Edoxaban 60mg

Oral administration of one tablet of edoxaban 60 mg once daily

DRUG

Apixaban 5mg

Oral administration of one tablet of apixaban 5 mg twice daily

DRUG

Rivaroxaban 20mg

Oral administration of one tablet of rivaroxaban 20 mg once daily

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Min-Gul Kim · Clinical Pharmacology Center, Jeonbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2023-07-17
Completion
2023-07-24

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 NCT05723510 on ClinicalTrials.gov