Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 b.i.d. treatment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asasantin ER (new formulation - low) | Experimental |
| |
| Asasantin ER (new formulation - medium) | Experimental |
| |
| Asasantin ER (new formulation- high) | Experimental |
| |
| Asasantin ER - commercial formulation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asasantin ER (new formulation - low) | Drug |
| ||
| Asasantin ER (new formulation - medium) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of dipyridamole | geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h) | 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 (Minimum measured concentration of the analyte) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
For Female Subjects:
During the interval between screening and start of drug administration tobacco and caffeine are restricted to avoid withdrawal when starting medication. As no relevant influence on Pharmacokinetic parameters is known moderate tobacco and caffeine consumption are allowed to facilitate trial participation (up to 10 cigarettes or 3 cigars or 3 pipes/day, and/or up to three cups of coffee respectively). Ovarian hormone substitution and oral contraception are allowed to be continued during the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Asasantin ER (new formulation - high) | Drug |
|
| Asasantin ER - 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 1 month |