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BUSPAR

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

BUSPAR · 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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Frequently asked questions about BUSPAR

What is BUSPAR used for?

BUSPAR is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating buspirone hydrochloride 30mg tablets under fasting and non-fasting conditions. The drug is not approved and remains in clinical development.

Who makes BUSPAR?

BUSPAR is being developed by Teva Pharmaceutical Industries Limited, whose ticker is TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers.

What phase is BUSPAR in?

BUSPAR is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers. The drug is investigational and has not been approved.

What clinical trials is BUSPAR in?

BUSPAR has two completed Phase 1 trials: NCT00840398, a non-fasting study of buspirone hydrochloride 30mg tablets with 24 participants, and NCT00840606, a fasting study with 70 participants. Both trials were conducted in the United States with healthy volunteers aged 18 years and older.

Is BUSPAR the same as buspirone?

BUSPAR is the brand name for buspirone hydrochloride, a small molecule. The clinical trials listed under BUSPAR evaluate buspirone hydrochloride 30mg tablets in healthy volunteers.