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Sponsors and Collaborators: |
GlaxoSmithKline Shionogi |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00858455 |
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.
Condition | Intervention | Phase |
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Healthy Volunteer |
Drug: GSK1349572 and MaaloxAdvanced Maximum Strength Drug: GSK1349572 and Maalox Advanced Maximum Strength Drug: GSK1349572 and One A Day Drug: GSK1349572 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Maalox® Advanced Maximum Strength and One A Day® Maximum on Pharmacokinetics of GSK1349572 in Healthy Adult Subjects |
Enrollment: | 16 |
Study Start Date: | January 2009 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Healthy Volunteers: Experimental
4 period cross over
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Drug: GSK1349572 and MaaloxAdvanced Maximum Strength
A single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength
Drug: GSK1349572 and Maalox Advanced Maximum Strength
A single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength
Drug: GSK1349572 and One A Day
A single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin
Drug: GSK1349572
A single dose of GSK1349572
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111602, ING111602 |
Study First Received: | January 22, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00858455 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy Volunteers Drug interation, Pharmacokinetics |
Aluminum magnesium hydroxide Magnesium Hydroxide Antacids Healthy |
Molecular Mechanisms of Pharmacological Action Aluminum magnesium hydroxide Antacids Pharmacologic Actions |