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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IN-C004

Detailed Description

An Open-label, Single-dose Clinical Study

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IN-C004	Drug: IN-C004; One time dose of IN-C004 taken orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of tegoprazan	Area under the plasma concentration-time curve of tegoprazan	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	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	pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: November 29, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IN_KOD_101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No