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

Phase 1

Completed

• Conditions: GERD
• Interventions: Drug: CKD-381(formulation I); Drug: CKD-381(formulation II); Drug: D026(Nexium 40mg)

• Registration Number: NCT03444402
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-23
• Study Start: 2018-03-02
• Status Verified: 2018-05
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	CKD-381(formulation I)	Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
Group A	CKD-381(formulation II)	Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
Group A	D026(Nexium 40mg)	Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
Group B	CKD-381(formulation I)	Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
Group B	CKD-381(formulation II)	Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
Group B	D026(Nexium 40mg)	Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
Group C	CKD-381(formulation I)	Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
Group C	CKD-381(formulation II)	Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
Group C	D026(Nexium 40mg)	Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)

Primary Outcome Measures

Name	Time	Method
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	0~24h	Evaluation PK esomeprazole after multiple dose

Secondary Outcome Measures

Name	Time	Method
Cmax(Maximum concentration of drug in plasma)	0~24h	Evaluation PK esomeprazole after single dose
Cmax,ss(Maximum concentration of drug in plasma at steady state)	0~24h	Evaluation PK esomeprazole after multiple dose
Tmax,ss(Time to maximum plasma concentration at steady state)	0~24h	Evaluation PK esomeprazole after multiple dose
t1/2(Terminal elimination half-life)	0~24h	Evaluation PK esomeprazole after single dose
Vss/F(Apparent Volume of distribution at steady state)	0~24h	Evaluation PK esomeprazole after multiple dose
AUClast(Area under the plasma drug concentration-time curve from 0 to last)	0~24h	Evaluation PK esomeprazole after single dose
Tmax(Time to maximum plasma concentration)	0~24h	Evaluation PK esomeprazole after single dose
CL/F(Apparent clearance)	0~24h	Evaluation PK esomeprazole after single dose
Vd/F(Apparent volume of distribution)	0~24h	Evaluation PK esomeprazole after single dose
R(Accumulation ratio)	0~24h	Evaluation PK esomeprazole after multiple dose
CLss/F(Apparent Clearance at steady state)	0~24h	Evaluation PK esomeprazole after multiple dose

Trial Locations

Locations (1)

Seoul University Hospital; 🇰🇷 Seoul, Korea, Republic of