Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

NCT00358371 | Completed Phase 1

• 1 other identifier: 103811
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Bacterial

Keywords

bioavailability flucloxacillin

Outcome Measures

Primary Outcomes (1)

• Absolute (Abs.) bioavailability, max. plasma conc., concentration-time curve (AUC) from 0 hto the last quantifiable conc., AUC from 0 h to infinity), timepoint of max. plasma conc., Halflife of drug elimination during the terminal phase

  Up to 60 Days

Secondary Outcomes (1)

• Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area

  Up to 60 Days

Study Arms (2)

Subjects receiving flucloxacillin 250 mg

EXPERIMENTAL

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

Drug: flucloxacillin 250 mg

Subjects receiving flucloxacillin 500 mg

EXPERIMENTAL

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

Drug: flucloxacillin 500 mg

Interventions

flucloxacillin 250 mg DRUG

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

Also known as: flucloxacillin

Subjects receiving flucloxacillin 250 mg

flucloxacillin 500 mg DRUG

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

Subjects receiving flucloxacillin 500 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• medical history,
• vital signs,
• physical examination,laboratory tests (blood and/or urine) with evidence of clinically significant conditions;
• 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,

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

Location

Related Links

• Results for study 103811 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Bacterial Infections

Interventions

Floxacillin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cloxacillin; Oxacillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2006
• First Posted: July 31, 2006
• Study Start: January 6, 2005
• Primary Completion: February 8, 2005
• Study Completion: February 8, 2005
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

DE (1)