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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: imported Probucol ( Lorelco) | Drug | Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BE parameters: AUC0-t | 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. | |
| BE parameters: Cmax | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters: Cmax | 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. | |
| Pharmacokinetic Parameters: Tmax | 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pei Hu, Dr. | Clinical Pharmacology Research Center Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Research Center Peking Union Medical College Hospital | Beijing | China |
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| Group B: Marketed Probucol ( Chang Tai) | Drug | Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O. |
|
| Pharmacokinetic Parameters: AUC0-t | 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 |
| Pharmacokinetic Parameters: AUC0-∞ | 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 |
| Pharmacokinetic Parameters: t1/2 | 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 |
| ID | Term |
|---|---|
| D011341 | Probucol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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