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The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asasantin ER (new formulation I - low) | Experimental |
| |
| Asasantin ER (new formulation III - medium) | Experimental |
| |
| Asasantin ER (new formulation II - high) | Experimental |
| |
| Asasantin ER (present commercial formulation) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asasantin ER (new formulation I - low) | Drug |
| ||
| Asasantin ER (new formulation III - medium) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of dipyridamole | represented by the sum of percentage of amount excreted from time zer0 to 10 h (%Ae 0-10 h), %Ae 10-24h | day 2, day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax urine (Maximum measured concentration of the analyte) | Urine collected fraction from 0 -3 hours as surrogate for Cmax | 0 to 3 hours after drug intake |
| Cmin urine (Minimum measured concentration of the analyte) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Asasantin ER (new formulation II - high) | Drug |
|
| Asasantin ER (present commercial formulation) | Drug |
|
Urine collected fraction from 8 - 10 hours as surrogate for Cmin
| 8- 10 hours after drug intake |
| %PTF urine (Peak trough fluctuation) | Estimated from the difference of percentage amount excreted from 1 - 3 hours (%Ae (1-3hours) and %Ae (8-10 hours) divided by the average excretion rate over the total dosing interval | Up to 10 hours after drug intake |
| Number of subjects with adverse events | up to 23 days |