Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects|
- Pharmacokinetic parameters [ Time Frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14 ] [ Designated as safety issue: Yes ]
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).
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||January 2013|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
probucol in healthy male subjects
multiple oral doses of probucol in single group of healthy male subjects
250mg (1 tablet) bid. p.o for 14 consecutive days
Other Name: Lorelco
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.
|Clinical Pharmacology Research Center, Peking Union Medical College Hospital|
|Principal Investigator:||Pei Hu, PHD||Clinical Pharmacology Research Center of Peking Union Medical College Hospital|