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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IN-C004

• Registration Number: NCT04654065
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

An Open-label, Single-dose Clinical Study

Study Timeline

• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2020-11-29
• Study First Posted: 2020-12-04
• Status Verified: 2021-01
• Study Start: 2021-01-04
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-05
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IN-C004	IN-C004	IN-C004

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of