A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: GERD

Treatments: Drug: CKD-382(formulation I); Drug: CKD-382(formulation II); Drug: D026

Study type: Interventional

Funder types: Industry

Identifiers

NCT04703374

A105_01BE2010

Details and patient eligibility

About

To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

Full description

A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Between 19 aged and 50 aged in healthy adult
2. Body weight more than 50kg
3. Body Mass Index more than 18.0 and under 27.0
4. Who has negative result on Helicobacter Pylori antibody test

Exclusion criteria

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history(including surgery) that can effect drug absorption
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

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

A

Experimental group

Description:

Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)

Treatment:

Drug: CKD-382(formulation II)

Drug: CKD-382(formulation I)

Drug: D026

B

Experimental group

Description:

Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)

Treatment:

Drug: CKD-382(formulation II)

Drug: CKD-382(formulation I)

Drug: D026

C

Experimental group

Description:

Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)

Treatment:

Drug: CKD-382(formulation II)

Drug: CKD-382(formulation I)

Drug: D026

D

Experimental group

Description:

Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)

Treatment:

Drug: CKD-382(formulation II)

Drug: CKD-382(formulation I)

Drug: D026

E

Experimental group

Description:

Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)

Treatment:

Drug: CKD-382(formulation II)

Drug: CKD-382(formulation I)

Drug: D026

F

Experimental group

Description:

Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)

Treatment:

Drug: CKD-382(formulation II)

Drug: CKD-382(formulation I)

Drug: D026