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Cephalexin

Phase 1

Infections, Respiratory Tract | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 7, 2017

Target and mechanism

ModalitySmall molecule

Also known as Cephalexin 1g tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

Cephalexin · 3 trials · 1 indication

Phase 1 3
NCT01767532Bioequivalence Study of Cephalexin Suspension 125Infections, Respiratory Tract
COMPLETED28 Analytics
NCT01767571Bioequivalence Study of Cephalexin Suspension 250Infections, Respiratory Tract
COMPLETED28 Analytics
NCT01767584Bioequivalence Study of Cephalexin Tablets 1gInfections, Respiratory Tract
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Cephalexin Suspension 125
Infections, Respiratory Tract
NCT0176753228
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PHASE1COMPLETED
Bioequivalence Study of Cephalexin Suspension 250
Infections, Respiratory Tract
NCT0176757128
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PHASE1COMPLETED
Bioequivalence Study of Cephalexin Tablets 1g
Infections, Respiratory Tract
NCT0176758426
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Study Endpoints

Primary Endpoints

Peak Plasma Concentration (CMAX) of cephalexin
0.0, 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 postdosage

Pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of cephalexin
0.0, 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 postdosage

Pharmacokinetics

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
A(reference)/B(test)EXPERIMENTALinitial administration of reference and cross-over to test
B(test)/A(reference)EXPERIMENTALinitial administration of test and cross-over to reference
A (reference)/ B (test)EXPERIMENTALinitial administration of reference and cross-over to test
B (test)/ A (reference)EXPERIMENTALinitial administration of test and cross-over to reference

Interventions

NameTypeDescription
Cephalexin 125 mg/5mlDRUGReference product 20 ml
Cephalexin 250mg/5mlDRUGTest product 10 ml
Cephalexin 1g tabletsDRUGReference product
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; ...

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