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The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabergoline tablets test formulation | Experimental | Administration order: Cabergoline test formulation(T), Cabergoline reference formulation(R) |
|
| Cabergoline tablets reference formulation | Experimental | Administration order: Cabergoline reference formulation(R), Cabergoline test formulation(T) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline tablets test formulation | Drug | Single oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | : 0 hours-72 hours post-administration | |
| AUC0-72h | 0 hours-72 hours post-administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Xiaoshan Hospital | Hangzhou | Zhejiang | 200233 | China |
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| ID | Term |
|---|---|
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Cabergoline tablets reference formulation | Drug | Single oral administration |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |