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

Phase 1CompletedNCT04654065

HK inno.N Corporation6 enrolled

Overview

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

An Open-label, Single-dose Clinical Study

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

IN-C004DRUG

One time dose of IN-C004 taken orally.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Chonbuk National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

AUCt of tegoprazan

Area under the plasma concentration-time curve 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

Cmax of tegoprazan

Maximum Plasma Concentration at Steady State 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

Tmax of tegoprazan

Time to reach Cmax

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

Data from ClinicalTrials.gov

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