Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers

Phase 1

• Conditions: Healthy
• Interventions: Drug: DWJ1392; Drug: DWC20164

• Registration Number: NCT03016520
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164 in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01-09
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-10
• Primary Completion: 2017-01-26
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

• No clinically significant findings
• Age 19-50 years at screening

Exclusion Criteria

• Who has allergy to investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test drug	DWJ1392	DWJ1392
Reference drug	DWC20164	DWC20164

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	0-72 hours
Maximum Plasma Concentration (Cmax)	0-72 hours

Trial Locations

Locations (1)

Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of