Status:
COMPLETED
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Bacterial
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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.
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 distribut...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 6 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00358371
Start Date
January 6 2005
End Date
February 8 2005
Last Update
September 29 2017
Active Locations (1)
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1
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487