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To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites.
In addition, the safety of these products will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolterodine | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of unchanged mirabegron | Day 14 | |
| Plasma concentration of unchanged tolterodine | Day 7, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT) | Day 7, Day 14 | |
| Safety assessed by the incidence of adverse events, vital signs, clinical labo-tests, and 12-lead ECG | Day -2, Day 8, Day 15, Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto | Japan |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| C520025 | mirabegron |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| mirabegron | Drug | Oral |
|
|
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |