This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1\*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1\*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
120
Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.
Clinical Pharmacology Research Center Peking Union Medical College Hospital
Beijing, China
BE parameters: AUC0-t
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
BE parameters: Cmax
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
Pharmacokinetic Parameters: Cmax
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
Pharmacokinetic Parameters: Tmax
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-t
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-∞
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: t1/2
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
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