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Zoloft

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 Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

Zoloft · 2 trials · 1 indication

Phase 1 2
NCT00836667Sertraline Hydrochloride 100 mg Tablets, FedHealthy
COMPLETED18 Analytics
NCT00836849Sertraline Hydrochloride 100 mg Tablets, FastingHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Sertraline Hydrochloride 100 mg Tablets, Fed
HealthyUnlock trial analytics
PHASE1COMPLETED
Sertraline Hydrochloride 100 mg Tablets, Fasting
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Zoloft® 100 mg TabletsDRUG1 x 100 mg, single-dose fed
Sertraline hydrochloride 100 mg TabletsDRUG1 x 100 mg, single-dose fed
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Eligibility Criteria

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

Inclusion Criteria: * Subjects will be females and/or males, non-smokers, 18 years of age and older. Female subjects will be post-menopausal or surgically sterilized. * Post-menopausal status is defined as absence of menses for the past 12 months. * Sterile status is defined as hysterectomy, bilate...

Countries:Canada
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Frequently asked questions about Zoloft

What is Zoloft used for?

Zoloft is a small molecule drug being developed by Teva Pharmaceutical Industries Limited for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating the drug in healthy individuals. The drug is not approved for any specific indication and remains investigational.

Who makes Zoloft?

Zoloft is being developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. The drug is currently in Phase 1 clinical trials, with studies conducted in Canada. Teva is responsible for the development and clinical testing of this investigational drug.

What phase is Zoloft in?

Zoloft is currently in Phase 1 clinical development. It has completed two Phase 1 trials, with a total enrollment of 42 participants. The drug is investigational and has not been approved by regulatory authorities. All completed trials were active-controlled, though they were not double-blinded.

What clinical trials is Zoloft in?

Zoloft has been studied in two completed Phase 1 clinical trials. The first trial, NCT00836667, evaluated Sertraline Hydrochloride 100 mg tablets under fed conditions in 18 healthy volunteers. The second trial, NCT00836849, evaluated the same tablets under fasting conditions in 24 participants. Both trials were conducted in Canada.

Is Zoloft the same as sertraline?

Zoloft is the brand name for sertraline hydrochloride, as indicated by the clinical trial titles that use the name Sertraline Hydrochloride. The drug is being developed by Teva Pharmaceutical Industries Limited and is currently in Phase 1 trials for healthy volunteers. It is an investigational small molecule drug.