NCT02757144

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

A Dose Block-randomized, Double-blind, Placebo- and Active-controlled, Single and Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWP14012	DWP14012 tablets
DRUG	Placebo	DWP14012 placebo-matching tablets, Active control placebo-matching tablets
DRUG	Esomeprazole	Nexium®

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-04-29
• Last updated: 2017-04-25

Locations

1 site across 1 country: South Korea