A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

November 30, 2025 updated by: HK inno.N Corporation

A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized, open-label, crossover study

[Part A] To evaluate and compare the pharmacokinetic and safety of co-administration of tegoprazan and naproxen versus administration of IN-M00002 tablet in healthy adult volunteers

[Part B] To evaluate the effects of food on the pharmacokinetic and safety of IN-M00002 tablet in healthy adult volunteers

Study Type

Interventional

Enrollment (Estimated)

74

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 Contact

Study Contact Backup

Study Locations

  • South Korea
      • Jeonju, South Korea
        • Jeonbuk National University Hospital
        • Contact:
          • Seol Ju Moon, MD, PhD
          • Phone Number: +82-63-270-3087
          • Email: sjmoon@jbcp.kr
        • Principal Investigator:
          • Seol Ju Moon, MD, PhD

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

  • Adult

Accepts Healthy Volunteers

Yes

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 ≥ 45 kg at screening
  • Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines
  • Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening
  • Those with a capability/willingness to participate throughout the study

Exclusion Criteria:

  • Medical history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, oncological, or immune disease (except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth)
  • Previous history of gastrointestinal disease (esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (except for simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption
  • Sitting systolic blood pressure < 90 mmHg or ≥ 140 mmHg or diastolic blood pressure < 60 mmHg or ≥ 90 mmHg at screening

  • Following findings of clinical laboratory tests:

    • ALT or AST value > twice the upper limit of normal (ULN)
  • History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)
  • Has taken any other investigational product within 6 months prior to the first dose of investigational product
  • History of serious alcohol or drug misuse and abuse within 1 year prior to screening
  • Administration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational product
  • Daily use of ≥ 20 cigarettes within 6 months prior to screening
  • Administration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational product
  • Whole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational product
  • Subjects who received a blood transfusion within 1 month prior to the first dose of the investigational product
  • Those who may be put at an increased risk due to the administration of the investigational product and study participation or have a severe acute/chronic medical or mental condition which may interfere with the interpretation of study results
  • Subjects with a history of hypersensitivity (e.g., asthma, rhinitis, nasal polyps, urticaria, or allergic reactions) to the components of tegoprazan or naproxen, benzimidazole derivatives, aspirin, or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)
  • Subjects currently receiving medications containing atazanavir, nelfinavir, or rilpivirine
  • Women with a positive pregnancy test, pregnant, or breastfeeding
  • Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))
  • Subjects unable to consume a high-fat diet provided during Part B of the clinical trial
  • 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
Experimental: Part A: Sequence 1 (Treatment A - Treatment B)
Period 1: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID Period 2: Single dose of IN-M00002 tablet BID
Drug: Tegoprazan
Tegoprazan 25 mg QD
Other Names:
  • K-CAB
Drug: Naproxen
Naproxen 500 mg BID
Other Names:
  • Naxen-F
Drug: IN-M00002
IN-M00002 tablet QD
Drug: IN-M00002
IN-M00002 tablet BID
Experimental: Part A: Sequence 2 (Treatment B - Treatment A)
Period 1: Single dose of IN-M00002 tablet BID Period 2: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID
Drug: Tegoprazan
Tegoprazan 25 mg QD
Other Names:
  • K-CAB
Drug: Naproxen
Naproxen 500 mg BID
Other Names:
  • Naxen-F
Drug: IN-M00002
IN-M00002 tablet QD
Drug: IN-M00002
IN-M00002 tablet BID
Experimental: Part B: Sequence 1 (Treatment C - Treatment D)
Period 1: Single dose of IN-M00002 tablet QD under fasted conditions Period 2: Single dose of IN-M00002 tablet QD under fed conditions
Drug: IN-M00002
IN-M00002 tablet QD
Drug: IN-M00002
IN-M00002 tablet BID
Experimental: Part B: Sequence 2 (Treatment D - Treatment C)
Period 1: Single dose of IN-M00002 tablet QD under fed conditions Period 2: Single dose of IN-M00002 tablet QD under fasted conditions
Drug: IN-M00002
IN-M00002 tablet QD
Drug: IN-M00002
IN-M00002 tablet BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt of tegoprazan
Time Frame: Up to 48 hours
Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration
Up to 48 hours
AUCt of naproxen
Time Frame: Up to 72 hours
Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration
Up to 72 hours
Cmax of tegoprazan
Time Frame: Up to 48 hours
Maximum plasma concentration of tegoprazan
Up to 48 hours
Cmax of naproxen
Time Frame: Up to 72 hours
Maximum plasma concentration of naproxen
Up to 72 hours

Collaborators and Investigators

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

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Seol Ju Moon, MD, Ph.D, Clinical Pharmacology Center, Jeonbuk National University Hospital

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 (Estimated)

December 27, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN_TNA_101

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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