Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358371
First received: July 27, 2006
Last updated: May 21, 2009
Last verified: May 2009
  Purpose

Primary objective:To study the absolute bioavailability, distribution and elimination parameters of flucloxacillin from two oral formulations of flucloxacillin in healthy male and/or female subjects.


Condition Intervention Phase
Healthy Subjects
Drug: flucloxacillin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Absolute (Abs.) bioavailability, max. plasma conc., concentration-time curve (AUC) from 0 hto the last quantifiable conc., AUC from 0 h to infinity), timepoint of max. plasma conc., Halflife of drug elimination during the terminal phase

Secondary Outcome Measures:
  • Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area

Estimated Enrollment: 24
Study Start Date: January 2005
Intervention Details:
    Drug: flucloxacillin
    Other Name: flucloxacillin
Detailed Description:

A mono-center, open, randomized, three-way, twelve-sequence, cross-over study to determine the extent of absorption (absolute bioavailability), rate of absorption and to further characterize distribution and elimination characteristics of a commercial 250 mg and a 500 mg capsule of flucloxacillin each given as a single oral dose vs. one 250 or 500 mg intravenous dose to 24 healthy male and/or female subjects in the fasting state

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers,
  • Caucasians,
  • Body Mass Index (BMI) between 19 and 27 kg/m 2;
  • physically and mentally healthy as judged by means of a medical and standard lab examination;
  • non-smokers,
  • ex-smokers or moderate smoker.

Exclusion criteria:

  • medical history,
  • vital signs,
  • physical examination,laboratory tests (blood and/or urine) with evidence of clinically significant conditions;
  • 12-lead electrocardiogram (ECG) with clinically significant abnormality;acute infection within 2 weeks preceding 1st study drug administration;any medication on a regular basis (exception females: oral contraceptives) and/or tricyclic antidepressants, antacids, histamine H2-receptor antagonists, antibiotics,
  • non steroid anti-inflammatory drugs or anticoagulants within 8 weeks before the 1st study drug administration and/or no agreement to take any of those drugs including Over-the-counter (OTC) drugs until the end of the follow- up examination;
  • no agreement not to take any medication,including OTC medicine, antacids, or analgesics within 2 weeks before 1st drug administration until the end of the follow-up examination;special diet or loss of > 5 kg within last month from a weight reduction diet; regularly consume of large quantities of alcohol (> 20g/day) and/or beverages containing methylxanthines e.g. caffeine (> 0.5L/day altogether);
  • no agreement not to consume: - any beverages or foods containing alcohol 48 h prior to 1st study drug administration until end of the follow-up examination;
  • any grapefruit products 7 days prior 1st study drug administration until end of the follow-up examination,
  • any beverages or foods containing methylxanthines as well as fruit-juices and any foods containing poppy seed 48 h before 1st drug administration of either study period until last blood sample of the respective study period was collected,
  • not to consume chewing during confinement;
  • history of: - allergy to flucloxacillin,
  • B-lactams and/or related drugs,
  • known hypersensitivity against the inactive ingredients of the study medication,
  • hypersensitivity to multiple drugs,
  • allergic diseases,
  • acute hay fever,
  • previous history of flucloxacillin-associated jaundice/hepatic dysfunction,
  • alcohol or drug abuse,
  • epilepsy or other seizure,
  • psychiatric illness, e.g. latent or manifest depression schizophrenia, or neurosis,
  • respiratory diseases,
  • surgery of the gastrointestinal tract (except appendectomy),
  • kidney diseases,
  • bleeding/coagulation disorder or severe anaemia,
  • glucose-6-phosphate dehydrogenase deficiency and/or chronic treatment or chronic pathology;
  • metabolic disease;
  • evidence for disorder in the metabolism of pharmaceuticals or other foreign compounds; cardiovascular diseases e.g. hypertension, hypotension or bradycardia;
  • associated disease that would interfere with the clinical course of the trial;
  • major illness during 3 month before commencement of the screening period,
  • gastrointestinal diseases;
  • reported or positive results from test of drugs of abuse (amphetamines, opiates, barbiturate, methadone, cannabinoids, cocaine, benzodiazepines);
  • Positive test for: alcohol, Hepatitis-B-antigen or Hepatitis-C-antibody, HIV-antibody;blood donor or blood loss including plasmapheresis within the last 3 months before the 1st study drug administration;
  • intake of depot injectable solutions (including study medication) within 6 month before 1st study administration;
  • intake of enzyme-inducing and/or organotoxic drugs within 4 weeks before 1st study drug administration;for females only: positive results from pregnancy tests;does not use or not agree to use adequate contraceptive methods during the study;
  • lactating woman.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358371

Locations
Germany
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00358371     History of Changes
Other Study ID Numbers: 103811
Study First Received: July 27, 2006
Last Updated: May 21, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
bioavailability flucloxacillin

Additional relevant MeSH terms:
Floxacillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014