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Relative Bioavailability Study in Healthy Subjects

NCT00924911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-06-26

No results posted yet for this study

Summary

Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as one of three investigational tablets compared to powder in a bottle formulation. Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2 blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322 pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed from each dose group.

Conditions

  • Infections, Bacterial

Interventions

DRUG

GSK1322322

Four different formulations of 1000mg of GSK1322322

DRUG

GSK1322322

GSK1322322 1000mg

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-04-27
Primary Completion
2009-07-09
Completion
2009-07-09

Countries

  • United States

Study Locations

More Related Trials

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 NCT00924911 on ClinicalTrials.gov