Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Infections, Bacterial
About this trial
This is an interventional treatment trial for Infections, Bacterial focused on measuring bioavailability flucloxacillin
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Subjects receiving flucloxacillin 250 mg
Subjects receiving flucloxacillin 500 mg
Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose