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during Period 1 due to numerous orthostatic AEs that occurred. Subsequently, RLD was reduced to 5 mg due to safety concerns.
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The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olanzapine Tablets 20 mg |
|
| 2 | Active Comparator | Zyprexa® Tablets 20 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine Tablets 20 mg | Drug | 20mg, single dose fasting |
| |
| Zyprexa® Tablets 20 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. | blood collections through 144 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas S Clark, M.D. | Kendle International Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendle International Inc. | Morgantown | West Virginia | 26505 | United States |
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| Label | URL |
|---|---|
| Mylan Pharmaceuticals Inc. - Clinical Trial Results | View source |
| Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use | View source |
| Recalls, Market Withdrawals and Safety Alerts |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
20mg, single dose fasting |
|
| View source |
| D006571 | Heterocyclic Compounds |