Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

NCT ID: NCT00358371

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-06
• Study Completion Date: 2005-02-08

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 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

Conditions

Infections, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects receiving flucloxacillin 250 mg

Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose

Group Type: EXPERIMENTAL

flucloxacillin 250 mg

Intervention Type: DRUG

Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose

Subjects receiving flucloxacillin 500 mg

Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose

Group Type: EXPERIMENTAL

flucloxacillin 500 mg

Intervention Type: DRUG

Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose

Interventions

flucloxacillin 250 mg

Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose

Intervention Type: DRUG

flucloxacillin 500 mg

Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Greifswald, Mecklenburg-Vorpommern, Germany

Countries

Germany

Other Identifiers

103811

Identifier Type: -

Identifier Source: org_study_id