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| Name | Class |
|---|---|
| Astellas Pharma Taiwan, Inc. | INDUSTRY |
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The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.
A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A group | Experimental | fasted condition then fed condition |
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| Part B group | Experimental | fed condition then fasted condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM178 | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of YM178 | Up to 96 hrs post dose | |
| AUC (area under the curve) of YM178 plasma concentration | Up to 96 hrs post dose |
| Measure | Description | Time Frame |
|---|---|---|
| tmax of YM178 plasma concentration | Up to 96 hrs post dose | |
| t1/2 of YM178 plasma concentration | Up to 96 hrs post dose | |
| Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei | Taiwan |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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| Up to 96 hrs post dose |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |