Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Co-administration of DWC20155/DWC20156; Drug: DWC20161

• Registration Number: NCT02947139
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-29
• Primary Completion: 2016-10-24
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-27
• Study Completion: 2016-11-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 DWC20155/DWC20156 on DWC20161 PK	Co-administration of DWC20155/DWC20156	To study effect of DWC20155/DWC20156 on DWC20161 PK
Study effect of DWC20161 on DWC20155/DWC20156 PK	DWC20161	To study effect of DWC20161 on DWC20155/DWC20156 PK
Study effect of DWC20161 on DWC20155/DWC20156 PK	Co-administration of DWC20155/DWC20156	To study effect of DWC20161 on DWC20155/DWC20156 PK
Study effect of DWC20155/DWC20156 on DWC20161 PK	DWC20161	To study effect of DWC20155/DWC20156 on DWC20161 PK

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Gyunggi, Korea, Republic of