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Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

Primary Purpose

Infections, Bacterial

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
flucloxacillin 250 mg
flucloxacillin 500 mg
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Bacterial focused on measuring bioavailability flucloxacillin

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Subjects receiving flucloxacillin 250 mg

Subjects receiving flucloxacillin 500 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2006
Last Updated
September 27, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00358371
Brief Title
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 6, 2005 (Actual)
Primary Completion Date
February 8, 2005 (Actual)
Study Completion Date
February 8, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Bacterial
Keywords
bioavailability flucloxacillin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving flucloxacillin 250 mg
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
Arm Title
Subjects receiving flucloxacillin 500 mg
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
Intervention Type
Drug
Intervention Name(s)
flucloxacillin 250 mg
Other Intervention Name(s)
flucloxacillin
Intervention Description
Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
Intervention Type
Drug
Intervention Name(s)
flucloxacillin 500 mg
Intervention Description
Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
Primary Outcome Measure Information:
Title
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
Time Frame
Up to 60 Days
Secondary Outcome Measure Information:
Title
Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area
Time Frame
Up to 60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17487
Country
Germany

12. IPD Sharing Statement

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Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)

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