Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers
- 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
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DWC20141+DWC20142 DWC20141, DWC20142 multiple dose of DWC20141 and DWC20142 DWC20142 DWC20142 multiple dose of DWC20142 DWC20141 DWC20141 multiple dose of DWC20141
- Primary Outcome Measures
Name Time Method Cmax,ss Multiple blood sample will be collected for 24 hours after last dosing in each of the periods AUCtau Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
- Secondary Outcome Measures
Name Time Method 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 t1/2 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
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