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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010841-29 | EudraCT Number |
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This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.
The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.
Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the combined administration of solifenacin and tamsulosin given as combination tablet EC905.
Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and verapamil.
On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is obtained.
Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.
Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: verapamil + EC905 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EC905 | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau | AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing) | Predose, Days 1, and 7-10 |
| Pharmacokinetics of solifenacin in plasma: AUCtau | AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing) | Predose, Days 1, and 7-10 |
| Pharmacokinetics of tamsulosin OCAS in plasma: Cmax | Cmax (maximum concentration) | Predose, Days 1, and 7-10 |
| Pharmacokinetics of solifenacin in plasma: Cmax | Cmax (maximum concentration) | Predose, Days 1, and 7-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil | Plasma: Ctrough (trough concentration), tmax (time to attain Cmax), CL/F (apparent total body clearance), PTR (peak trough ratio) Urine: AUCtau, Cmax, Ctrough, CL/F, tmax | Predose, Days 27-30 |
| Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Aster | Paris | 75015 | France |
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| verapamil | Drug | Oral |
|
AE (adverse events), clinical laboratory tests, vital signs, ECG, physical examination |
| Screening to ESV (10 days after the last dosing) |
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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