Pharmacokinetics and Safety Study of Probucol by Multiple Administration 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|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590901
|Clinical Pharmacology Research Center, Peking Union Medical College Hospital|
|Principal Investigator:||Pei Hu, PHD||Clinical Pharmacology Research Center of Peking Union Medical College Hospital|