Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
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|ClinicalTrials.gov Identifier: NCT01590901|
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : June 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Probucol||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||January 2013|
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
- Pharmacokinetic parameters [ Time Frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|