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

November 20, 2020 updated by: HK inno.N Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tegoprazan 50 mg
Multiple doses of tegoprazan alone once daily (QD) for 7 days
Drug: Tegoprazan
Tegoprazan 50 mg tablet
Other Names:
  • K-CAB
Active Comparator: NSAIDs
Multiple doses of NSAIDs alone twice daily (BID) for 7 days
Drug: Naproxen
Naproxen 500 mg tablet
Other Names:
  • Naxen-F
Drug: Aceclofenac
Aceclofenac 100 mg tablet
Other Names:
  • Airtal
Drug: Celecoxib
Celecoxib 200 mg capsule
Other Names:
  • Celebrex 200 mg
Active Comparator: Tegoprazan 50 mg + NSAIDs
Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days
Drug: Tegoprazan
Tegoprazan 50 mg tablet
Other Names:
  • K-CAB
Drug: Naproxen
Naproxen 500 mg tablet
Other Names:
  • Naxen-F
Drug: Aceclofenac
Aceclofenac 100 mg tablet
Other Names:
  • Airtal
Drug: Celecoxib
Celecoxib 200 mg capsule
Other Names:
  • Celebrex 200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
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
pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Min-Gul Kim, MD, PhD, Chonbuk university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2020

Primary Completion (Actual)

July 26, 2020

Study Completion (Actual)

July 29, 2020

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN_APA_117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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