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Cefdinir

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials4
Total Enrollment128
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00834535Cefdinir Capsules 300 mg, Non-fastingPHASE1 COMPLETED 32 — — Jul 1, 2005Aug 1, 2005Aug 20, 20242 United States
NCT00835484Cefdinir Capsules 300 mg, FastingPHASE1 COMPLETED 32 — — Jul 1, 2005Jul 1, 2005Aug 20, 20242 United States
NCT00835549Cefdinir for Oral Suspension 250 mg/5mL, Non-fastingPHASE1 COMPLETED 32 — — Mar 1, 2005Mar 1, 2005Aug 20, 20242 United States
NCT00834574Cefdinir for Oral Suspension 250 mg/5mL, FastingPHASE1 COMPLETED 32 — — Feb 1, 2005Mar 1, 2005Aug 20, 20242 United States
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Study Endpoints
Primary Endpoints
Cmax (Maximum Observed Concentration)
Blood samples collected over a 14 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 14 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 14 hour period.

Bioequivalence based on AUC0-inf.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Cefdinir Capsules 300 mgDRUG1 x 300 mg, single-dose non-fasting
OMNICEF® Capsule 300 mgDRUG1 x 300 mg, single-dose non-fasting
OMNICEF® 300 mgDRUG1 x 300 mg, single-dose fasting
Cefdinir for oral suspension 250 mg/5mLDRUG1 x 250 mg/5mL, single-dose non-fasting
OMNICEF® for oral suspension 250 mg/5mLDRUG1 x 250 mg/5mL, single-dose non-fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. the subject's body mass index (BMI) should be 19 kg/m² - 30 kg/m², inclusive. * Screening procedures: Each subject will complete the scree...

Countries:United States
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