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

Phase 1

• Conditions: GERD
• Interventions: Drug: CKD-382, D860, D027

• Registration Number: NCT05108038
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-07
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	CKD-382, D860, D027	Period 1: D860 Period 2: D027 Period 3: CKD-382
D	CKD-382, D860, D027	Period 1: D860 Period 2: CKD-382 Period 3: D027
A	CKD-382, D860, D027	Period 1: CKD-382 Period 2: D860 Period 3: D027
B	CKD-382, D860, D027	Period 1: CKD-382 Period 2: D027 Period 3: D860
E	CKD-382, D860, D027	Period 1: D027 Period 2: D860 Period 3: CKD-382
F	CKD-382, D860, D027	Period 1: D027 Period 2: CKD-382 Period 3: D860

Primary Outcome Measures

Name	Time	Method
Primary Pharmacokinetic Endpoint	0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours	AUCt,ss Evaluation after multiple dose; -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state
Primary Pharmacodynamic Endpoint	24 hours after multiple dose for 7 days compared to baseline	Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose

Secondary Outcome Measures

Name	Time	Method
(2) Secondary Pharmacokinetic Endpoint	0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours	Vz/F Evaluation after single dose; -Vz/F: Apparent Volume of Distribution
(1) Secondary Pharmacokinetic Endpoint	0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours	PTF Evaluation after multiple dose; -PTF: Peak to Trough Fluctuation
(1) Secondary Pharmacodynamic Endpoint	24 hours after first dose compared to baseline	Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose
(2) Secondary Pharmacodynamic Endpoint	24 hours after first dose and multiple dose for 7 days	Percent of time with gastric pH≤4 for 24-hour interval after first or 7th dose

Trial Locations

Locations (1)

Chungbuk Ntional University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of