Status:
COMPLETED
A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
GERD
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects
Detailed 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
Eligibility Criteria
Inclusion
- Between 19 aged and 50 aged in healthy male adult
- Body weight more than 55kg
- Body Mass Index more than 18.5 and under 25
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 that can effect drug absorption or surgery.
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03444402
Start Date
March 2 2018
End Date
May 4 2018
Last Update
May 24 2018
Active Locations (1)
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1
Seoul University Hospital
Seoul, South Korea