Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

NCT ID: NCT04654078

Last Updated: 2021-03-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2021-02-15

Brief Summary

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To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Detailed Description

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An Open-label, Randomized, Single-dose, Crossover Study

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Group 1

Group Type EXPERIMENTAL

IN-C004 with water

Intervention Type DRUG

One time dose of IN-C004 taken with water

IN-C004 without water

Intervention Type DRUG

One time dose of IN-C004 taken without water

K-CAB tab. with water

Intervention Type DRUG

One time dose of K-CAB tab. taken with water

Group 2

Group 2

Group Type EXPERIMENTAL

IN-C004 with water

Intervention Type DRUG

One time dose of IN-C004 taken with water

IN-C004 without water

Intervention Type DRUG

One time dose of IN-C004 taken without water

K-CAB tab. with water

Intervention Type DRUG

One time dose of K-CAB tab. taken with water

Group 3

Group 3

Group Type EXPERIMENTAL

IN-C004 with water

Intervention Type DRUG

One time dose of IN-C004 taken with water

IN-C004 without water

Intervention Type DRUG

One time dose of IN-C004 taken without water

K-CAB tab. with water

Intervention Type DRUG

One time dose of K-CAB tab. taken with water

Group 4

Group 4

Group Type EXPERIMENTAL

IN-C004 with water

Intervention Type DRUG

One time dose of IN-C004 taken with water

IN-C004 without water

Intervention Type DRUG

One time dose of IN-C004 taken without water

K-CAB tab. with water

Intervention Type DRUG

One time dose of K-CAB tab. taken with water

Group 5

Group 5

Group Type EXPERIMENTAL

IN-C004 with water

Intervention Type DRUG

One time dose of IN-C004 taken with water

IN-C004 without water

Intervention Type DRUG

One time dose of IN-C004 taken without water

K-CAB tab. with water

Intervention Type DRUG

One time dose of K-CAB tab. taken with water

Group 6

Group 6

Group Type EXPERIMENTAL

IN-C004 with water

Intervention Type DRUG

One time dose of IN-C004 taken with water

IN-C004 without water

Intervention Type DRUG

One time dose of IN-C004 taken without water

K-CAB tab. with water

Intervention Type DRUG

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

Intervention Type DRUG

IN-C004 without water

One time dose of IN-C004 taken without water

Intervention Type DRUG

K-CAB tab. with water

One time dose of K-CAB tab. taken with water

Intervention Type DRUG

Other Intervention Names

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IN-C004 IN-C004 K-CAB tab.

Eligibility Criteria

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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.
* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Korea

Other Identifiers

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IN_KOD_102

Identifier Type: -

Identifier Source: org_study_id

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