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

GERD Clinical Trial

Official title:

A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558425
• Other study ID #: 173BE18010
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2018
• Est. completion date: September 14, 2018

Study information

• Verified date: June 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 subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 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 Investigational product, additives or benzimidazole family.

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• CKD-381
1 tablet administered before the breakfast during 7 days
• D026
1 tablet administered before the breakfast during 7 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul Nat'l 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 for Esomeprazole after multiple dose	0~24h
Primary	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