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Buspirone

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

Buspirone · 2 trials · 1 indication

Phase 1 2
NCT00840398Buspirone Hydrochloride 30mg Tablets, Non-FastingHealthy
COMPLETED24 Analytics
NCT00840606Buspirone Hydrochloride 30mg Tablets, FastingHealthy
COMPLETED70 Analytics
PHASE1COMPLETED
Buspirone Hydrochloride 30mg Tablets, Non-Fasting
HealthyUnlock trial analytics
PHASE1COMPLETED
Buspirone Hydrochloride 30mg Tablets, Fasting
HealthyUnlock trial analytics

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 to 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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