Status:
UNKNOWN
A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
GERD
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects
Detailed 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
Eligibility Criteria
Inclusion
- Between 19 aged and 50 aged in healthy adult
- Body weight more than 50kg
- Body Mass Index more than 18.0 and under 27.0
- Who has negative result on Helicobacter Pylori antibody test
Exclusion
- 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 or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04703374
Start Date
September 25 2020
End Date
September 1 2021
Last Update
January 11 2021
Active Locations (1)
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1
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea