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CompletedNCT04654078Updated Mar 29, 2021

Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

A Phase 1 interventional study of IN-C004 with water and IN-C004 without water in Healthy, sponsored by HK inno.N Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-29.

Sponsored by HK inno.N Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Read the detailed description

An Open-label, Randomized, Single-dose, Crossover Study

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

Exclusion criteria

Exclusion Criteria:

  • History or evidence of clinically significant disease
  • History of drug/alcohol abuse
  • Participated in other studies and received investigational products within 6 months prior to the first study dose.
  • AST(GOT) or ALT(GPT) > 2 X upper limit of normal at screening
  • Not able to use a medically acceptable contraceptive method throughout the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Group 1

    Group 1

    Drug: IN-C004 with water · Drug: IN-C004 without water · Drug: K-CAB tab. with water

  • Experimental
    Group 2

    Group 2

    Drug: IN-C004 with water · Drug: IN-C004 without water · Drug: K-CAB tab. with water

  • Experimental
    Group 3

    Group 3

    Drug: IN-C004 with water · Drug: IN-C004 without water · Drug: K-CAB tab. with water

  • Experimental
    Group 4

    Group 4

    Drug: IN-C004 with water · Drug: IN-C004 without water · Drug: K-CAB tab. with water

  • Experimental
    Group 5

    Group 5

    Drug: IN-C004 with water · Drug: IN-C004 without water · Drug: K-CAB tab. with water

  • Experimental
    Group 6

    Group 6

    Drug: IN-C004 with water · Drug: IN-C004 without water · Drug: K-CAB tab. with water

Interventions

  • DrugIN-C004 with water

    One time dose of IN-C004 taken with water

    Also known as: IN-C004

  • DrugIN-C004 without water

    One time dose of IN-C004 taken without water

    Also known as: IN-C004

  • DrugK-CAB tab. with water

    One time dose of K-CAB tab. taken with water

    Also known as: K-CAB tab.

06

What researchers measure

Primary outcomes

  1. AUCt of tegoprazan

    Area under the plasma concentration-time curve of tegoprazan

    Time frame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  2. Cmax of tegoprazan

    Maximum Plasma Concentration at Steady State of tegoprazan

    Time frame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  3. AUCt of tegoprazan metabolite M1

    Area under the plasma concentration-time curve of tegoprazan metabolite M1

    Time frame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour

  4. Cmax of tegoprazan metabolite M1

    Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1

    Time frame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

07

Study locations

1 site
  • Chonbuk National University Hospital
    Jeonju, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04654078
Lead sponsor
HK inno.N Corporation
Responsible party
Sponsor
First posted
Dec 4, 2020
Start date
Jan 18, 2021
Primary completion
Feb 5, 2021
Completion
Feb 15, 2021
Last update
Mar 29, 2021

Study contacts

Min-Gul Kim
principal investigator · Chonbuk National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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