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Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults

NCT01073891 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-01

No results posted yet for this study

Summary

The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is to see how the body absorbs, distributes and gets rid of the study drug. The absorption of the drug administered in a different dosage form may be altered due to the influence of different excipients used. The safety of moxifloxacin when administered as an oral liquid formulation will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children.

Conditions

  • Healthy

Interventions

DRUG

Moxifloxacin (Avelox, BAY12-8039)

Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions

DRUG

Moxifloxacin (BAY12-8039)

Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fasting conditions

DRUG

Moxifloxacin (BAY12-8039)

Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fed conditions

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-11-30
Completion
2011-01-31

Countries

  • Germany

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 NCT01073891 on ClinicalTrials.gov