Overview

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects

Status:
Completed
Trial end date:
2019-01-11
Target enrollment:
0
Participant gender:
Male
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 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Treatments:
Amoxicillin
Clarithromycin
Dexlansoprazole
Lansoprazole
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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