Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

Phase 1

• Conditions: Healthy
• Interventions: Drug: Co-administration of DWC20155 and DWC20156; Drug: DWJ1386 Tab.

• Registration Number: NCT03016494
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-10
• Last Update Posted: 2017-01-10
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• BMI≥18.5 and ≤27.0 kg/m2
• No clinically significant findings
• Age 19-55 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/Reference Drug	DWJ1386 Tab.	DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
Reference/Test Drug	Co-administration of DWC20155 and DWC20156	co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.
Test/Reference Drug	Co-administration of DWC20155 and DWC20156	DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
Reference/Test Drug	DWJ1386 Tab.	co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	0-24 hours
Area under the plasma concentration versus time curve (AUC)	0-24 hours

Trial Locations

Locations (1)

Busan Paik Hospital; 🇰🇷 Busan, Busanjin-gu, Korea, Republic of