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

NCT ID: NCT04639804

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-06

Study Completion Date

2020-07-29

Brief Summary

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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

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

Conditions

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Healthy

Keywords

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drug-drug interaction pharmacokinetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tegoprazan 50 mg

Multiple doses of tegoprazan alone once daily (QD) for 7 days

Group Type ACTIVE_COMPARATOR

Tegoprazan

Intervention Type DRUG

Tegoprazan 50 mg tablet

NSAIDs

Multiple doses of NSAIDs alone twice daily (BID) for 7 days

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablet

Aceclofenac

Intervention Type DRUG

Aceclofenac 100 mg tablet

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsule

Tegoprazan 50 mg + NSAIDs

Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days

Group Type ACTIVE_COMPARATOR

Tegoprazan

Intervention Type DRUG

Tegoprazan 50 mg tablet

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablet

Aceclofenac

Intervention Type DRUG

Aceclofenac 100 mg tablet

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsule

Interventions

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Tegoprazan

Tegoprazan 50 mg tablet

Intervention Type DRUG

Naproxen

Naproxen 500 mg tablet

Intervention Type DRUG

Aceclofenac

Aceclofenac 100 mg tablet

Intervention Type DRUG

Celecoxib

Celecoxib 200 mg capsule

Intervention Type DRUG

Other Intervention Names

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K-CAB Naxen-F Airtal Celebrex 200 mg

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min-Gul Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk university hospital

Locations

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Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Countries

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South Korea

References

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Moon SJ, Shin N, Kang M, Kim B, Kim MG. Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects. Clin Ther. 2022 Jul;44(7):930-944.e1. doi: 10.1016/j.clinthera.2022.06.002. Epub 2022 Jul 1.

Reference Type DERIVED
PMID: 35787943 (View on PubMed)

Other Identifiers

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IN_APA_117

Identifier Type: -

Identifier Source: org_study_id