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

NCT03487562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-06-26

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

DWP14012 Amg

DWP14012 Amg

DRUG

DWP14012 Bmg

DWP14012 Bmg

DRUG

Clarithromycin

Clarithromycin 500 mg

DRUG

Amoxicillin

Amoxicillin 1 g

DRUG

Lansoprazole

Lansoprazole 30 mg

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-08
Primary Completion
2019-01-11
Completion
2019-01-11

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487562 on ClinicalTrials.gov