Last updated: 11/03/2018 00:18:09
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Healthy volunteers,
- medical history,
- vital signs,
Inclusion and exclusion 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
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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