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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01073891
First received: February 22, 2010
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Moxifloxacin (BAY12-8039)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Single-dose, Open-label, Randomized, Non-blinded, Three-fold Crossover Study in Healthy Subjects to Compare the Bioavailability of Moxifloxacin (BAY12-8039) 400 mg Tablet and 400 mg Oral Suspension Under Fasting Conditions, and to Investigate the Effect of Food on the Bioavailability of 400 mg Suspension.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics, as measured by maximum drug concentration in plasma and systemic drug exposure [ Time Frame: 3 days per period (from before until 72 hours after drug administration) ] [ Designated as safety issue: No ]
  • Comparison of systemic drug exposures (tablet versus oral solution; oral solution with versus without food) [ Time Frame: 3 days per period (from before until 72 hours after drug administration) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety/tolerability as assessed by clinical labs and adverse events. [ Time Frame: From first subject entering clinics until last subject completes last period ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
Oral intake of a 400 mg single dose after an overnight fast (=reference treatment)
Experimental: Arm 2 Drug: Moxifloxacin (BAY12-8039)
Oral intake of a 400 mg single dose of the oral liquid dosage form after an overnight fast
Experimental: Arm 3 Drug: Moxifloxacin (BAY12-8039)
Oral intake of a 400 mg single dose of the oral liquid dosage form directly after ingestion of a high fat, high calorie breakfast

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects;
  • Age: 18 to 55 years (inclusive)
  • Body mass index (BMI): above/equal 18 and below/equal 30 kg/m²;
  • Women of childbearing age must have a negative pregnancy test and must use adequate contraception throughout the study and for 4 weeks afterwards

Exclusion Criteria:

  • Clinically relevant findings in the ECG
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Known hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Relevant diseases within the last 4 weeks prior to the first study drug administration
  • Febrile illness within 1 week before the first study drug administration
  • Patients with a history of tendon disease/disorder related to quinolone treatment.
  • Congenital or documented acquired QT prolongation
  • Regular use of medicines (with the exception of contraceptives)
  • Pregnancy or lactation
  • Regular use of therapeutic or recreational drugs
  • Smoking more than 25 cigarettes daily
  • Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
  • Suspicion of drug or alcohol abuse
  • Special diets preventing the subjects from eating the standard meals during the study
  • Regular daily consumption of more than 1 L of xanthin-containing beverages
  • Donation of more than 100 mL of blood within 4 weeks before the first study drug administration or of approximately 500 mL in the preceding 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073891

Locations
Germany
Wuppertal, Nordrhein-Westfalen, Germany, 42096
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01073891     History of Changes
Other Study ID Numbers: 14413, 2009-017070-21
Study First Received: February 22, 2010
Last Updated: November 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Bayer:
Pharmacokinetics
Bioavailability
Food effect
Oral liquid formulation

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014