NCT03487562

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-04-08
• Primary completion: 2019-01-11
• Completion: 2019-01-11
• First posted: 2018-04-04
• Last updated: 2019-06-26

Locations

1 site across 1 country: South Korea