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BUSPAR

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 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 Enrollment94
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00840398Buspirone Hydrochloride 30mg Tablets, Non-FastingPHASE1 COMPLETED 24Dec 1, 2001Dec 1, 2001Aug 19, 20241 United States
NCT00840606Buspirone Hydrochloride 30mg Tablets, FastingPHASE1 COMPLETED 70Dec 1, 2001Apr 1, 2002Aug 19, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence based on Cmax
Blood samples collected over 24 hour period
Bioequivalence based on AUC0-inf
Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
Blood samples collected over 24 hour period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BUSPAR® 30 mg TabletDRUG1 x 30 mg, single-dose fed
Buspirone Hydrochloride 30 mg TabletDRUG1 x 30 mg, single-dose fed
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30. * Screening Procedures: Each volunteer will complete the screening pro...

Countries:United States
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