Status:
COMPLETED
A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
GERD
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Detailed Description
A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Eligibility Criteria
Inclusion
- Between 19 aged and 50 aged in healthy adult
- Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
- Have 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 evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04830930
Start Date
April 21 2021
End Date
July 26 2021
Last Update
August 18 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080