NCT04171687

Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Explore the Drug Interaction of Tegoprazan or RAPA113 and Clopidogrel After Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.

Detailed description

Evaluation Criteria: * Primary outcome Pharmacodynamic assessments using P2Y12 assay * Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F of Clopidogrel * 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 75mg	Clopidogrel 75 mg tablet
DRUG	Tegoprazan 50 mg	Tegoprazan 50 mg tablet
DRUG	RAPA113	RAPA113 tablet

Timeline

• Start date: 2019-10-21
• Primary completion: 2020-02-07
• Completion: 2020-04-09
• First posted: 2019-11-21
• Last updated: 2020-05-08

Locations

1 site across 1 country: South Korea