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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04639804

Enrollment

Registered

2020-11-23

Start date

2020-06-06

Completion date

2020-07-29

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

drug-drug interaction, pharmacokinetic

Brief 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

Interventions

DRUGTegoprazan

Tegoprazan 50 mg tablet

DRUGNaproxen

Naproxen 500 mg tablet

DRUGAceclofenac

Aceclofenac 100 mg tablet

DRUGCelecoxib

Celecoxib 200 mg capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult aged ≥ 19 and \< 55 year-old at screening * Body mass index (BMI) ≥ 19.0 kg/m2 and \< 27.0 kg/m2 with a body weight ≥ 55 kg at screening.

Exclusion criteria

* History or evidence of clinically significant disease * History of GI disease or surgery that may affect the absorption of a drug * Laboratory test result which falls into the following values( ALT or AST \> 2 × upper limit of normal (ULN)) * History of regular alcohol consumption exceeding 210 g/week within 6 months * Daily use of ≥ 20 cigarettes within 6 months * Has taken any investigational agent within 6 months prior to the first dose of IMP * Subjects who are considered ineligible to participate in this study at the discretion of the investigator.

Design outcomes

Primary

Measure	Time frame	Description
AUCτ of tegoprazan and NSAIDs	pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7	Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs
Css,max of tegoprazan and NSAIDs	pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7	Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026