Clinical Pharmacology Research Center Peking Union Medical College Hospital
Beijing, China
NCT Number: NCT02196805
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.
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Notify Me18 year–40 year
Male
Interventional
Not applicable
Beijing, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration
Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.
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.
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.
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.
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
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
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
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
Otsuka Beijing Research Institute
Industry
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