A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: GERD

Treatments: Drug: CKD-381(formulation II); Drug: CKD-381(formulation I); Drug: D026(Nexium 40mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444402

173HPS17013

Details and patient eligibility

About

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Full description

A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Enrollment: 18 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Between 19 aged and 50 aged in healthy male adult
2. Body weight more than 55kg
3. Body Mass Index more than 18.5 and under 25

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 that can effect drug absorption or surgery.
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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18 participants in 3 patient groups

Group A

Experimental group

Description:

Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)

Treatment:

Drug: D026(Nexium 40mg)

Drug: CKD-381(formulation II)

Drug: CKD-381(formulation I)

Group B

Experimental group

Description:

Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)

Treatment:

Drug: D026(Nexium 40mg)

Drug: CKD-381(formulation II)

Drug: CKD-381(formulation I)

Group C

Experimental group

Description:

Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)

Treatment:

Drug: D026(Nexium 40mg)

Drug: CKD-381(formulation II)

Drug: CKD-381(formulation I)