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Zaleplon

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

Zaleplon · 2 trials · 1 indication

Phase 1 2
NCT00829868Zaleplon 10 mg Capsules Under Non-Fasting ConditionsHealthy
COMPLETED42 Analytics
NCT00829998Zaleplon 10mg Capsules Under Fasting ConditionsHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Zaleplon 10 mg Capsules Under Non-Fasting Conditions
Healthy
NCT0082986842
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PHASE1COMPLETED
Zaleplon 10mg Capsules Under Fasting Conditions
Healthy
NCT0082999840
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Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 12 hour period

Bioequivalence based on Cmax

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

Bioequivalence based on AUC0-inf

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

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
ZaleplonEXPERIMENTALZaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
Sonata®ACTIVE_COMPARATORSonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period

Interventions

NameTypeDescription
Zaleplon 10 mg CapsulesDRUG1 x 10 mg
SONATA® 10 mg capsulesDRUG1 x 10 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * non-smokers * at least 18 years of age * subjects will have a BMI (body mass index) of 30 or less Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption(past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or car...

Countries:United States
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Frequently asked questions about Zaleplon

What is Zaleplon?

Zaleplon is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy individuals. The drug is being studied in capsule form at a 10 mg dose.

What is Zaleplon used for?

Zaleplon is being studied for use in healthy individuals, as part of Phase 1 clinical trials. The trials are designed to evaluate the drug under fasting and non-fasting conditions. It is not yet approved for any specific medical condition.

Who makes Zaleplon?

Zaleplon is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's effects in healthy volunteers.

What phase is Zaleplon in?

Zaleplon is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with no active trials currently ongoing.

What clinical trials is Zaleplon in?

Zaleplon has two completed Phase 1 clinical trials: NCT00829868, which studied Zaleplon 10 mg capsules under non-fasting conditions, and NCT00829998, which studied the same dose under fasting conditions. Both trials enrolled healthy adults in the United States.

Is Zaleplon the same as any other drug?

Zaleplon is a distinct drug entity with no alternative names provided. It is being studied as a 10 mg capsule formulation in clinical trials. No other names or brand names have been associated with this drug in the available information.