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The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm AB | Experimental | A will be a single tablet RSG XR 8 milligram (mg) manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm AB subject will receive A regimen in Period 1 and B regimen in Period 2.There will be wash-out period of 5 days between doses. |
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| Treatment Arm BA | Experimental | A will be a single tablet RSG XR 8 mg manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm BA subject will receive B regimen in Period 1 and A regimen in Period 2. There will be wash-out period of 5 days between doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSG XR | Drug | RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water. |
| Measure | Description | Time Frame |
|---|---|---|
| PK samples | at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements. | Up to 32 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Neuss | North Rhine-Westphalia | 41460 | Germany |
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| Label | URL |
|---|---|
| Results for study AXR107453 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |