NCT04639804

Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.

Detailed description

A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tegoprazan	Tegoprazan 50 mg tablet
DRUG	Naproxen	Naproxen 500 mg tablet
DRUG	Aceclofenac	Aceclofenac 100 mg tablet
DRUG	Celecoxib	Celecoxib 200 mg capsule

Timeline

• Start date: 2020-06-06
• Primary completion: 2020-07-26
• Completion: 2020-07-29
• First posted: 2020-11-23
• Last updated: 2020-11-23

Locations

1 site across 1 country: South Korea