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

Phase 1

• Conditions: GERD
• Interventions: Drug: CKD-382(formulation I); Drug: CKD-382(formulation II); Drug: D026

• Registration Number: NCT04703374
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2020-09-25
• Status Verified: 2021-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D	D026	Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)
A	D026	Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)
B	CKD-382(formulation II)	Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)
B	D026	Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)
C	CKD-382(formulation II)	Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)
A	CKD-382(formulation II)	Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)
D	CKD-382(formulation I)	Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)
A	CKD-382(formulation I)	Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)
B	CKD-382(formulation I)	Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)
C	CKD-382(formulation I)	Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)
C	D026	Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)
F	CKD-382(formulation II)	Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)
D	CKD-382(formulation II)	Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)
E	CKD-382(formulation I)	Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)
E	CKD-382(formulation II)	Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)
E	D026	Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)
F	CKD-382(formulation I)	Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)
F	D026	Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)

Primary Outcome Measures

Name	Time	Method
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor	Baseline versus Multiple dose during 7 days
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose	0~24h

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Chungcheongbuk-do, Korea, Republic of