NCT04221321

Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers

An Open-label, Randomized, Multiple-dose, Replicated Crossover Study to Evaluate Drug-drug Interaction Following Co-administration of Tegoprazan or RAPA114 With Atorvastatin in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (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 RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.

Detailed description

\[Pharmacokinetic Assessments\] : Blood concentration of atorvastatin, 2-OH atorvastatin * Primary outcome: AUCτ, Css,max of atorvastatin * Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio \[Sefety Assessments\] : 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	Atorvastatin 40 mg	Atorvastatin 40 mg
DRUG	Tegoprazan 50 mg	Tegoprazan 50 mg tablet
DRUG	RAPA114	RAPA114 tablet

Timeline

• Start date: 2020-01-07
• Primary completion: 2020-03-12
• Completion: 2020-04-20
• First posted: 2020-01-09
• Last updated: 2020-12-01

Locations

1 site across 1 country: South Korea