The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
58
Drug: DWP10292 tablets, oral administration, multiple administration
Placebo tablets, oral administration, multiple administrations
Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration
Composite of Pharmacokinetics
Peak Plasma Concentration (Cmax)
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics
Area under the plasma concentration versus time curve (AUC)
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics
Mean residence time (MRT)
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics
Accumulation index
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
[Safety & tolerability] Incidence of adverse events related with drug
Adverse events, Physical exam, Vital sign, laboratory (CBC, chemistry, U/A etc)
Time frame: 4 weeks
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Placebo tablets, oral administration, multiple administrations