Last updated: 11/03/2018 00:18:09

Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

GSK study ID
103811
See study documents
Clinicaltrials.gov ID
NCT00358371
EudraCT ID
2004-004493-81
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Up to 60 Days

Secondary outcomes:

Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area

Timeframe: Up to 60 Days

Interventions:
  • Drug: flucloxacillin 250 mg
  • Drug: flucloxacillin 500 mg
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Bacterial
    Product
    flucloxacillin
    Collaborators
    Not applicable
    Study date(s)
    January 2005 to February 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy volunteers,
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Greifswald, Mecklenburg-Vorpommern, Germany, 17487
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-08-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study 103811 can be found on the GSK Clinical Study Register.
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