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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: GERD

Treatments: Drug: CKD-381; Drug: D026

Study type: Interventional

Funder types: Industry

Identifiers

NCT03558425

173BE18010

Details and patient eligibility

About

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

Enrollment: 41 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 Investigational product, additives or benzimidazole family.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 2 patient groups

TR group

Experimental group

Description:

Period 1: Test drug(CKD-381) Period 2: Reference drug(D026)

Treatment:

Drug: D026

RT group

Experimental group

Description:

Period 1: Reference drug(D026) Period 2: Test drug(CKD-381)

Treatment:

Drug: CKD-381