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A Study to Evaluate the Effect of Antacid and Multivitamin and Mineral Tablet on the Study Drug GSK1349572

NCT00858455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2009-06-05

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteer

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858455 on ClinicalTrials.gov