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

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04639804
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
1.7
Actual Duration (Months)
34.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jun 6, 2020
Actual Primary Completion Date :
Jul 26, 2020
Actual Study Completion Date :
Jul 29, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonbuk National University Hospital Jeonju Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT04639804
    Other Study ID Numbers:
    • IN_APA_117
    First Posted:
    Nov 23, 2020
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by HK inno.N Corporation
    drug-drug interaction
    pharmacokinetic
    Additional relevant MeSH terms:
    Celecoxib
    Naproxen
    Aceclofenac

    Study Results

    No Results Posted as of Nov 23, 2020