NCT03364985

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers

A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of DWP16001 Following Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• 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 DWP16001 after oral administration in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWP16001	DWP16001 tablets
DRUG	Placebo	DWP16001 placebo-matching tablets, Active control placebo-matching tablets
DRUG	Dapagliflozin	Forxiga®

Timeline

• Start date: 2017-12-03
• Primary completion: 2019-05-21
• Completion: 2019-07-30
• First posted: 2017-12-07
• Last updated: 2019-08-21

Locations

1 site across 1 country: South Korea