MedPath

Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: DWC20141, DWC20142
Registration Number
NCT02369302
Lead Sponsor
Daewoong Pharmaceutical Co. LTD.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
30
Inclusion Criteria
  1. Healthy adult male volunteers aged 19 to 45 years
  2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
  3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints
Exclusion Criteria
  1. 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.

  2. 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
  3. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
DWC20141+DWC20142DWC20141, DWC20142multiple dose of DWC20141 and DWC20142
DWC20142DWC20142multiple dose of DWC20142
DWC20141DWC20141multiple dose of DWC20141
Primary Outcome Measures
NameTimeMethod
Cmax,ssMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtauMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary Outcome Measures
NameTimeMethod
TmaxMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic RatioMultiple blood sample will be collected for 24 hours after last dosing in each of the periods
t1/2Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Cmin,ssMultiple blood sample will be collected for 24 hours after last dosing in each of the periods

Trial Locations

Locations (1)

Inje University College of Medicine Busan Paik Hospital

🇰🇷

Busan, Busanjin-gu, Korea, Republic of

Inje University College of Medicine Busan Paik Hospital
🇰🇷Busan, Busanjin-gu, Korea, Republic of

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.