Recent Updates
Recently added Catalysts

Valacyclovir

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01149499Valacyclovir 1000 mg Tablet Under Fasting ConditionsPHASE1 COMPLETED 60 — — Jan 1, 2005Jan 1, 2005Jun 23, 20101 United States
NCT01149460Valacyclovir 1000 mg Tablet Under Fed ConditionsPHASE1 COMPLETED 36 — — Sep 1, 2004Sep 1, 2004Aug 21, 20241 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Cmax (maximum observed concentration of drug substance in plasma)
Blood samples collected over 16 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 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 16 hour period

Bioequivalence based on AUC0-inf

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir
Blood samples collected over 12 hour period

Bioequivalence based on Cmax

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir
Blood samples collected over 12 hour period

Bioequivalence based on AUC0-t

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir
Blood samples collected over 12 hour period

Bioequivalence based on AUC0-inf

Secondary Endpoints
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir
Blood samples collected over 24 hour period
AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir
Blood samples collected over 24 hour period
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir
Blood samples collected over 24 hour period
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
ValacyclovirEXPERIMENTALTest 1000 mg Valacyclovir Tablet
ValtrexACTIVE_COMPARATORReference Listed 1000 mg Valtrex Tablet
Interventions
NameTypeDescription
ValacyclovirDRUG1000 mg Tablet
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Male or female, non-smokers, 18 years of age and older. * Capable of consent * BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2 Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study: * Clinically significant il...

Countries:United StatesCanada
Unlock Eligibility Criteria