The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and safety profiles of phencynonate hydrochloride in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
2mg/tablet
General Clinical Research Center for New Drug Trial, Tri-Service General Hospital
Taipei, Taiwan
PK parameters(1)Cmax,Tmax,Elimination half-life,AUC,Vd/F,Clt/F,MRT,relative BA and percentage of protein binding of plasma PCNH and its metabolite (2) D∞(u)and Clr of urine PCNH and its metabolite
Time frame: 5 or 10 days
Safety Variables:AE/lab. exam./PE/Vital signs/ECG
Time frame: 5 to 10 days
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