Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

• Status: Completed
• Trial end date: 2005-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Floxacillin

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.