A Phase 1 interventional study of Probucol in Healthy, sponsored by Otsuka Beijing Research Institute. Completed at 1 site in China. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by Otsuka Beijing Research Institute · Phase 1, Interventional, and Supportive care
The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.
This is a single dose, single period, multiple administration, open-labeled trial in one investigation center.
The screening examination will be completed from Day -14 to Day -2 before investigational medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day 1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.
Otsuka Beijing Research Institute is the lead sponsor of 36 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)
TG: ≥ 150 mg/dL
Use of any of the following within the specified period prior to scheduled investigational medicinal product (IMP) administration
multiple oral doses of probucol in single group of healthy male subjects
Drug: Probucol
250mg (1 tablet) bid. p.o for 14 consecutive days
Also known as: Lorelco
Pharmacokinetic parameters
Pharmacokinetic parameters: Day 1 (Plasma PK parameters over the 24h dosing period): Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h; Day3,5,7,9,11,12,13:C24h; Day 14: Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h, Clast, tlast, t1/2,z,Lambdaz, DF, CL/F, Vz/F, AUC_%Extrap; Accumulation evaluation parameters: Rpred, R14,ac(AUC24h), R14,ac(Cmax), R14,ac(C24h), R14,ac\[AUC(0-10h)\], R14,ac\[AUC(10-24h)\], R14,ac(Cmax1), R14,ac(Cmax2).
Time frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Otsuka Beijing Research Institute