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A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anpl-one SR Tab. 300mg | Experimental | Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets |
|
| Sarpodipil SR Tab. 300mg | Active Comparator | Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anpl-one SR Tab. 300mg | Drug | Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration | Cmax | 0-24hr |
| Area under the plasma concentration versus time curve | AUC | 0-24hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daewoong pharmatceutical | Seoul | Gangnam-gu | 06170 | South Korea |
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open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
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| Sarpodipil SR Tab. 300mg | Drug | Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets |
|
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