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| ID | Type | Description | Link |
|---|---|---|---|
| ING111602 |
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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
The purpose is to study the effect of Maalox® and One A Day® on the pharmacokinetics of GSK1349572, and also to compare the safety of GSK1349572 when administered alone and when administered with Maalox® and One A Day®. There are four dosing periods in this study, each period requires a 4 night stay. A follow-up visit is also required at approximately 7 days after the last dose administration. Starting from the first period to the follow-up, it will take about 1 month. Screening visit is required to be completed within 30 days prior to the first dose.
MAALOX® is a registered trademark of Novartic Consumer Health, LLC. ONE A DAY® is a registered trademark of Bayer Healthcare LLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | 4 period cross over |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1349572 and MaaloxAdvanced Maximum Strength | Drug | A single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single dose plasma GSK1349572 PK parameters including AUC(0-∞), Cmax, and C24 will be obtained to compare single dose plasma GSK1349572 PK with that of GSK1349572 after dministration with Maalox and One A Day as per the study design in the protocol | PK samples will be commected and analyzed starting with pre-dose and going for up to 72 hours post dose in each period in each study period |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters, including adverse event, concurrent medication,clinical laboratory, ECG, and vital signs assessments. Single dose plasma GSK1349572 PK parameters: AUC(0-t), AUC(0-24), tlag, tmax, CL/F, and t1/2. | Data will be collected from Dosing until the final follow-up after completion of all study periods. |
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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 | Buffalo | New York | 14202 | United States |
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| GSK1349572 and Maalox Advanced Maximum Strength | Drug | A single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength |
|
| GSK1349572 and One A Day | Drug | A single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin |
|
| GSK1349572 | Drug | A single dose of GSK1349572 |
|
| ID | Term |
|---|---|
| C562325 | dolutegravir |
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