Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers
NCT ID: NCT04654078
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2021-01-18
2021-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
Group 1
IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Group 2
Group 2
IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Group 3
Group 3
IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Group 4
Group 4
IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Group 5
Group 5
IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Group 6
Group 6
IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Interventions
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IN-C004 with water
One time dose of IN-C004 taken with water
IN-C004 without water
One time dose of IN-C004 taken without water
K-CAB tab. with water
One time dose of K-CAB tab. taken with water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of drug/alcohol abuse
* Participated in other studies and received investigational products within 6 months prior to the first study dose.
* AST(GOT) or ALT(GPT) \> 2 X upper limit of normal at screening
* Not able to use a medically acceptable contraceptive method throughout the study.
19 Years
55 Years
ALL
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Min-Gul Kim
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, , South Korea
Countries
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Other Identifiers
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IN_KOD_102
Identifier Type: -
Identifier Source: org_study_id
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