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Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

Sponsored by GlaxoSmithKline

About this trial

Last updated 8 years ago

Study ID

103811

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 45 Years
All
All

Trial Timing

Ended 20 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.