An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects

Daewoong Pharmaceutical Co. LTD.1 site in 1 country30 target enrollmentJanuary 2015

ConditionsHealthy

InterventionsDWC20141 DWC20142 DWC20141, DWC20142

DrugsDWC20141 DWC20142 DWC20141, DWC20142

Overview

Phase: Phase 1
Intervention: DWC20141
Conditions: Healthy
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 30
Locations: 1
Primary Endpoint: Cmax,ss
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult male volunteers aged 19 to 45 years
•A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
•A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria

•A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
•A subject who shows the following result in clinical laboratory test
•AST, ALT \> 1.25 times of the upper limit of normal range
•PR ≥ 210 msec
•QRS ≥ 120 msec
•QT ≥ 500 msec
•QTcF ≥ 500 msec
•Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Arms & Interventions

DWC20141

multiple dose of DWC20141

Intervention: DWC20141

DWC20142

multiple dose of DWC20142

Intervention: DWC20142

DWC20141+DWC20142

multiple dose of DWC20141 and DWC20142

Intervention: DWC20141, DWC20142

Outcomes

Primary Outcomes

Cmax,ss

Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

AUCtau

Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary Outcomes

Tmax(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
Metabolic Ratio(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
Cmin,ss(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)
t1/2(Multiple blood sample will be collected for 24 hours after last dosing in each of the periods)