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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
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: 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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014