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flucloxacillin

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00358371Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)PHASE1 COMPLETED 24Jan 6, 2005Feb 8, 2005Sep 29, 20171 Germany
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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 — 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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