Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04654065
Collaborator
(none)
6
1
1
1
182.6
Study Details
Study Description
Brief Summary
To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
An Open-label, Single-dose Clinical Study
Study Design
Study Type:
Interventional
Actual Enrollment
:
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
Actual Study Start Date
:
Jan 4, 2021
Actual Primary Completion Date
:
Jan 5, 2021
Actual Study Completion Date
:
Jan 5, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IN-C004 IN-C004 |
Drug: IN-C004
One time dose of IN-C004 taken orally.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chonbuk National University Hospital | Jeonju | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
- Principal Investigator: Min-Gul Kim, Chonbuk National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
HK inno.N Corporation
ClinicalTrials.gov Identifier:
NCT04654065
Other Study ID Numbers:
- IN_KOD_101
First Posted:
Dec 4, 2020
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No