NCT06164834

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults

Detailed description

Evaluation Criteria: * Primary outcome Pharmacodynamic assessments using P2Y12 assay * Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, Vd,ss/F, and PTF 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 75 mg	Clopidogrel 75 mg tablet
DRUG	Tegoprazan 25 mg	Tegoprazan 25 mg tablet
DRUG	Esomeprazole 20mg	Esomeprazole 20 mg tablet

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-12-11
• Last updated: 2023-12-11

Locations

1 site across 1 country: South Korea