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Famciclovir

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 Trials2
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00834431Famciclovir 500 mg Tablets Under Fasting ConditionsPHASE1 COMPLETED 36 — — Aug 1, 2004Sep 1, 2004Aug 20, 20242 United States, Canada
NCT00834444Famciclovir 500 mg Tablets Under Non-Fasting ConditionsPHASE1 COMPLETED 36 — — Aug 1, 2004Sep 1, 2004Aug 20, 20242 United States, Canada
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Study Endpoints
Primary Endpoints
Cmax = Maximum Observed Concentration.
Blood samples collected over a 16 hour period.

Bioequivalence based on Cmax.

AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
Blood samples collected over a 16 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 16 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
Famciclovir 500 mg TabletsDRUG1 x 500 mg, single-dose fasting
Famvir® 500 mg TabletsDRUG1 x 500 mg, single-dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * All subjects selected for this study will be at least 18 years of age. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history. *...

Countries:United StatesCanada
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