A Study to Evaluate the 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, D860, D027

Study type: Interventional

Funder types: Industry

Identifiers

NCT05108038

A105_02PK2115

Details and patient eligibility

About

to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Full description

A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Enrollment: 42 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between 19 aged and 50 aged in healthy adult
• Body weight more than 50kg
• BMI more than 18.0 and under 27.0
• Who has negative result on Helicobacter Pylori antibody test

Exclusion criteria

• 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
• Have a gastrointestinal disease history(including surgery) that can effect drug absorption
• Hypersensitivity reaction of 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)

---

42 participants in 6 patient groups

A

Experimental group

Description:

Period 1: CKD-382 Period 2: D860 Period 3: D027

Treatment:

Drug: CKD-382, D860, D027

B

Experimental group

Description:

Period 1: CKD-382 Period 2: D027 Period 3: D860

Treatment:

Drug: CKD-382, D860, D027

C

Experimental group

Description:

Period 1: D860 Period 2: D027 Period 3: CKD-382

Treatment:

Drug: CKD-382, D860, D027

D

Experimental group

Description:

Period 1: D860 Period 2: CKD-382 Period 3: D027

Treatment:

Drug: CKD-382, D860, D027

E

Experimental group

Description:

Period 1: D027 Period 2: D860 Period 3: CKD-382

Treatment:

Drug: CKD-382, D860, D027

F

Experimental group

Description:

Period 1: D027 Period 2: CKD-382 Period 3: D860

Treatment:

Drug: CKD-382, D860, D027