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Completed

NCT Number: NCT04654078

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

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

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

IN-C004 with water

Drug

One time dose of IN-C004 taken with water

Other names: IN-C004

IN-C004 without water

Drug

One time dose of IN-C004 taken without water

Other names: IN-C004

K-CAB tab. with water

Drug

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

Other names: K-CAB tab.

Primary outcomes

  1. AUCt of tegoprazan

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

    Area under the plasma concentration-time curve of tegoprazan

  2. Cmax of tegoprazan

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

    Maximum Plasma Concentration at Steady State of tegoprazan

  3. AUCt 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

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

  4. Cmax 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

    Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2020
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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