Skip to main content
OpenTrials
Completed

NCT Number: NCT04654065

Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers

To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.

Completed

Looking for future studies?

Notify Me

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, Single-dose Clinical 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.
  • Not able to use a medically acceptable contraceptive method throughout the study.

Treatment and study plan

IN-C004

Drug

One time dose of IN-C004 taken orally.

Primary outcomes

  1. AUCt of tegoprazan

    Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

    Area under the plasma concentration-time curve of tegoprazan

  2. Cmax of tegoprazan

    Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

    Maximum Plasma Concentration at Steady State of tegoprazan

  3. Tmax of tegoprazan

    Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

    Time to reach Cmax

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption 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
Jan 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.