Status:
COMPLETED
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012...
Eligibility Criteria
Inclusion
- Healthy adult males aged between 19 and 50 at screening
- Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- Part I: Those who have been helicobacter pylori negative at screening Part II: Those who have been helicobacter pylori positive at screening
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Exclusion
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Those whose plasma AST (SGOT) and ALT (SGPT) exceed to the upper limit of the normal range
- Those who have anatomical disability in insertion and maintenance of pH meter catheter
Key Trial Info
Start Date :
April 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03487562
Start Date
April 8 2018
End Date
January 11 2019
Last Update
June 26 2019
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea