NCT03814642

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants

A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel According to CYP2C19 Genotypes in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers.

Detailed description

Evaluation Criteria: * Pharmacodynamic assessments using P2Y12 assay * Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clopidogrel 75 mg	Clopidogrel 75 mg tablet
DRUG	Tegoprazan 50 mg	Tegoprazan 50 mg tablet
DRUG	Esomeprazole 20 mg	Esomeprazole 20 mg tablet

Timeline

• Start date: 2019-01-21
• Primary completion: 2019-07-22
• Completion: 2019-07-22
• First posted: 2019-01-24
• Last updated: 2019-10-21

Locations

1 site across 1 country: South Korea