Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers

Phase 1

• Conditions: Healthy
• Interventions: Drug: Co-administration of DWC20155/DWC20156; Drug: DWC20163

• Registration Number: NCT03005223
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20163 in Healthy Volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-29
• Study Start: 2017-01-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16
• Primary Completion: 2017-05
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• Accepts healthy volunteers

Exclusion Criteria

• Who has allergy to investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study effect of DWC20163 on DWC20155/DWC20156 PK	Co-administration of DWC20155/DWC20156	To study effect of DWC20163 on DWC20155/DWC20156 PK
Study effect of DWC20163 on DWC20155/DWC20156 PK	DWC20163	To study effect of DWC20163 on DWC20155/DWC20156 PK
Study effect of DWC20155/DWC20156 on DWC20163 PK	DWC20163	To study effect of DWC20155/DWC20156 on DWC20163 PK
Study effect of DWC20155/DWC20156 on DWC20163 PK	Co-administration of DWC20155/DWC20156	To study effect of DWC20155/DWC20156 on DWC20163 PK

Primary Outcome Measures

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