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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IN-C004 without water; Drug: K-CAB tab. with water; Drug: IN-C004 with water

Study type: Interventional

Funder types: Industry

Identifiers

NCT04654078

IN_KOD_102

Details and patient eligibility

About

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

Full description

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

Enrollment: 48 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Group 1

Experimental group

Description:

Group 1

Treatment:

Drug: IN-C004 with water

Drug: K-CAB tab. with water

Drug: IN-C004 without water

Group 2

Experimental group

Description:

Group 2

Treatment:

Drug: IN-C004 with water

Drug: K-CAB tab. with water

Drug: IN-C004 without water

Group 3

Experimental group

Description:

Group 3

Treatment:

Drug: IN-C004 with water

Drug: K-CAB tab. with water

Drug: IN-C004 without water

Group 4

Experimental group

Description:

Group 4

Treatment:

Drug: IN-C004 with water

Drug: K-CAB tab. with water

Drug: IN-C004 without water

Group 5

Experimental group

Description:

Group 5

Treatment:

Drug: IN-C004 with water

Drug: K-CAB tab. with water

Drug: IN-C004 without water

Group 6

Experimental group

Description:

Group 6

Treatment:

Drug: IN-C004 with water

Drug: K-CAB tab. with water

Drug: IN-C004 without water