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The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and safety profiles of phencynonate hydrochloride in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Experimental | 1mg / 0.5 tablet |
|
| cohort 2 | Experimental | 2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China |
|
| cohort 3 | Experimental | 4mg / 2 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phencynonate hydrochloride | Drug | 2mg/tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters(1)Cmax,Tmax,Elimination half-life,AUC,Vd/F,Clt/F,MRT,relative BA and percentage of protein binding of plasma PCNH and its metabolite (2) D∞(u)and Clr of urine PCNH and its metabolite | 5 or 10 days | |
| Safety Variables:AE/lab. exam./PE/Vital signs/ECG | 5 to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaoh S Lin, M.D. | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center for New Drug Trial, Tri-Service General Hospital | Taipei | 114 | Taiwan |
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| ID | Term |
|---|---|
| C504860 | 3-methyl-3-azabicyclo(3,3,1)nonanyl-9-alpha-yl-alpha-cyclopentyl-alpha-phenyl-alpha-glycolate |
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