Skip to main content
OpenTrials
Completed

NCT Number: NCT04639804

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tegoprazan

Drug

Tegoprazan 50 mg tablet

Other names: K-CAB

Naproxen

Drug

Naproxen 500 mg tablet

Other names: Naxen-F

Aceclofenac

Drug

Aceclofenac 100 mg tablet

Other names: Airtal

Celecoxib

Drug

Celecoxib 200 mg capsule

Other names: Celebrex 200 mg

Primary outcomes

  1. AUCτ of tegoprazan and NSAIDs

    Time frame: 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

  2. Css,max of tegoprazan and NSAIDs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 23, 2020
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.