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Cephalexin

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 26, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Cephalexin · 5 trials · 2 indications

Phase 1 5
NCT02490670A Study of Cephalexin Liquid in Healthy ParticipantsHealthy
COMPLETED28 Analytics
NCT02123459A Study of Cephalexin Suspension in Healthy ParticipantsHealthy Volunteers
COMPLETED28 Analytics
NCT02123472A Study of Cephalexin Liquid for Pediatrics in Healthy Adults ParticipantsHealthy Volunteers
COMPLETED28 Analytics
NCT02100826A Study of Cephalexin in Healthy ParticipantsHealthy Volunteers
COMPLETED28 Analytics
NCT02123446A Study of Cephalexin Capsules in Healthy ParticipantsHealthy Volunteers
COMPLETED28 Analytics
PHASE1COMPLETED
A Study of Cephalexin Liquid in Healthy Participants
Healthy
NCT0249067028
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PHASE1COMPLETED
A Study of Cephalexin Suspension in Healthy Participants
Healthy Volunteers
NCT0212345928
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PHASE1COMPLETED
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
Healthy Volunteers
NCT0212347228
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PHASE1COMPLETED
A Study of Cephalexin in Healthy Participants
Healthy Volunteers
NCT0210082628
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PHASE1COMPLETED
A Study of Cephalexin Capsules in Healthy Participants
Healthy Volunteers
NCT0212344628
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Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose
Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period
Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose
Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Secondary Endpoints

Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cephalexin (Reference)EXPERIMENTALCephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Cephalexin (Test)ACTIVE_COMPARATORCephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.

Interventions

NameTypeDescription
CephalexinDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participation will be voluntary. * The body mass index of participants should be between 18-27. * Participants should have a good health status. * Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (m...

Countries:Mexico
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