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flucloxacillin

Phase 1

Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

flucloxacillin · 1 trial · 1 indication

Phase 1 1
NCT00358371Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)Infections, Bacterial
COMPLETED24 Analytics
PHASE1COMPLETED
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Infections, BacterialUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area
Up to 60 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving flucloxacillin 250 mgEXPERIMENTALSubjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
Subjects receiving flucloxacillin 500 mgEXPERIMENTALSubjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose

Interventions

NameTypeDescription
flucloxacillin 250 mgDRUGSubjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
flucloxacillin 500 mgDRUGSubjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Germany
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Frequently asked questions about flucloxacillin

What is flucloxacillin used for?

Flucloxacillin is a small molecule antibiotic used for bacterial infections. It is being developed by GSK plc for the treatment of infections caused by susceptible bacteria. The drug is currently in Phase 1 clinical development, meaning it is still investigational and has not yet been approved for commercial use.

Who makes flucloxacillin?

Flucloxacillin is developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's bioavailability and pharmacokinetic profile in healthy volunteers.

What phase is flucloxacillin in?

Flucloxacillin is in Phase 1 clinical development. A Phase 1 trial has been completed to assess the bioavailability of flucloxacillin capsules at 250 mg and 500 mg doses. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is flucloxacillin in?

Flucloxacillin has one completed Phase 1 clinical trial registered under NCT00358371, titled "Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)". This randomized, controlled study enrolled 24 participants in Germany to evaluate the drug's bioavailability in healthy volunteers aged 18 years and older.

Is flucloxacillin the same as other antibiotics?

Flucloxacillin is a distinct antibiotic compound developed by GSK plc. It belongs to the penicillin class of antibiotics and is specifically designed to treat bacterial infections. No alternative names for this drug have been established in the clinical development program.