Infections, BacterialPhase 1NCT00358371
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
A Phase 1 study testing flucloxacillin 250 mg and flucloxacillin 500 mg in people with Infections, Bacterial, run by GlaxoSmithKline at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Bacterial
- What is being tested?
- flucloxacillin 250 mg and flucloxacillin 500 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jan 2005to 8 Feb 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, 17487
About this study
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
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.
Read the 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
- Being tested
- flucloxacillin 250 mg, flucloxacillin 500 mg
- Keywords
- bioavailability flucloxacillin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flucloxacillin 250 mgDrug
Also called flucloxacillin
Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
flucloxacillin 500 mgDrug
Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: flucloxacillin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study start6 Jan 2005
- Primary completion8 Feb 2005
- Study completion8 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358371
- Sponsor's protocol ID
- 103811
- Status last verified
- Sep 2017
- First submitted
- 27 Jul 2006
- Last updated
- 29 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00358371
- Acronym / sponsor ID
- 103811
- Conditions
- Infections, Bacterial
- Keywords
- bioavailability flucloxacillin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2005 (actual)
- Primary completion
- 8 Feb 2005 (actual)
- Study completion
- 8 Feb 2005 (actual)
- First posted
- 31 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving flucloxacillin 250 mg | Experimental | Drug: flucloxacillin 250 mgSubjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose |
| Subjects receiving flucloxacillin 500 mg | Experimental | Drug: flucloxacillin 500 mgSubjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (35 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flucloxacillin 250 mgAlso: flucloxacillinSubjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose | Drug | Subjects receiving flucloxacillin 250 mg |
| flucloxacillin 500 mgSubjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose | Drug | Subjects receiving flucloxacillin 500 mg |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Results for study 103811 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing flucloxacillin 250 mg and flucloxacillin 500 mg in people with Infections, Bacterial, run by GlaxoSmithKline at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.