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

An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04654065

Enrollment

Registered

2020-12-04

Start date

2021-01-04

Completion date

2021-01-05

Last updated

2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

An Open-label, Single-dose Clinical Study

Interventions

DRUGIN-C004

One time dose of IN-C004 taken orally.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
AUCt of tegoprazan	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
Cmax of tegoprazan	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
Tmax of tegoprazan	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026