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Cephalexin

Phase 1

Anti-Infective Agents | Small molecule | Other |Bayer AG|Last Updated: Apr 3, 2015

Target and mechanism

ModalitySmall molecule

Also known as Cephalexin capsules (Optocef, BAYO5448 ), Cephalexin suspension (Optocef, BAYO5448 ), Cephalexin suspension (Optocef, BAYO5448)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

Cephalexin · 3 trials · 1 indication

Phase 1 3
NCT01105208Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin SuspensionAnti-Infective Agents
COMPLETED26 Analytics
NCT01073553Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin CapsulesAnti-Infective Agents
COMPLETED26 Analytics
NCT01073540Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin SuspensionAnti-Infective Agents
COMPLETED26 Analytics
PHASE1COMPLETED
Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
Anti-Infective Agents
NCT0110520826
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PHASE1COMPLETED
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
Anti-Infective Agents
NCT0107355326
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PHASE1COMPLETED
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
Anti-Infective Agents
NCT0107354026
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Study Endpoints

Primary Endpoints

Least square estimator of average maximum plasmatic concentration (log transformed)
After two months
Least square estimator of area under the pharmacokinetic curve (log transformed)
After two months

Secondary Endpoints

Time at which maximum concentration is reached
After two months
Area under the pharmacokinetic curve from time=0 to last blood sample
After two months
Clearance constant of plasmatic concentrations of study drug
After two months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Cephalexin suspension (Optocef, BAYO5448 )DRUGSingle dose of 500 mg / 10 mL
Cephalexin suspension (Keflex)DRUGSingle dose of 500 mg / 20 mL
Cephalexin capsules (Optocef, BAYO5448 )DRUGSingle dose of 500 mg (One 500 mg capsule)
Cephalexin capsules (Keflex)DRUGSingle dose of 500 mg (Two 250 mg capsules)
Cephalexin suspension (Optocef, BAYO5448)DRUGSingle dose of 500 mg / 10 mL
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis Exclusion Criteria: * History of illnesses or any organic abnormalities that could affect the results of...

Countries:Mexico
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