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

Daewoong Pharmaceutical Co. LTD.48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DWP14012 AmgDRUG

DWP14012 Amg

DWP14012 BmgDRUG

DWP14012 Bmg

ClarithromycinDRUG

Clarithromycin 500 mg

Amoxicillin

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state