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

GERD Clinical Trial

Official title:

A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444402
• Other study ID #: 173HPS17013
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2018
• Est. completion date: May 4, 2018

Study information

• Verified date: May 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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 Esomeprazole, additives or benzimidazole family.

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• CKD-381(formulation I)
1 tablet administered before the breakfast during 7 days
• CKD-381(formulation II)
1 tablet administered before the breakfast during 7 days
• D026(Nexium 40mg)
1 tablet administered before the breakfast during 7 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	Cmax,ss(Maximum concentration of drug in plasma at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	Tmax,ss(Time to maximum plasma concentration at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	t1/2(Terminal elimination half-life)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	R(Accumulation ratio)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	CLss/F(Apparent Clearance at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	Vss/F(Apparent Volume of distribution at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Secondary	Cmax(Maximum concentration of drug in plasma)	Evaluation PK esomeprazole after single dose	0~24h
Secondary	AUClast(Area under the plasma drug concentration-time curve from 0 to last)	Evaluation PK esomeprazole after single dose	0~24h
Secondary	Tmax(Time to maximum plasma concentration)	Evaluation PK esomeprazole after single dose	0~24h
Secondary	t1/2(Terminal elimination half-life)	Evaluation PK esomeprazole after single dose	0~24h
Secondary	CL/F(Apparent clearance)	Evaluation PK esomeprazole after single dose	0~24h
Secondary	Vd/F(Apparent volume of distribution)	Evaluation PK esomeprazole after single dose	0~24h