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

GERD Clinical Trial

Official title:

A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703374
• Other study ID #: A105_01BE2010
• Status: Recruiting
• Phase: Phase 1
• Start date: September 25, 2020
• Est. completion date: September 2021

Study information

• Verified date: January 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: MinKyu Park, Ph.D
• Phone: 043-269-8708
• Email: mk_park[@]cbnuhctc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• CKD-382(formulation I)
1 tablet administered under fasting condition for 7days
• CKD-382(formulation II)
1 tablet administered under fasting condition for 7days
• D026
1 tablet administered under fasting condition for 7days

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do

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 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