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JZoloft

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Jan 27, 2021

JZoloft development status

Highest phase Phase 1
Registered trials 5 across 1 sponsor since Jan 2008

JZoloft target and mechanism

ModalitySmall molecule

Also known as sertraline hydrochloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

JZoloft clinical trials

JZoloft · 1 trial · 1 indication

Phase 1 1
NCT01699724Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese SubjectsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects
Healthy
NCT0169972430
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Study Endpoints

Primary Endpoints

AUC from zero to the last sampling point (AUCt) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Secondary Endpoints

Cmax and AUCt of sertraline after dose of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Time of maximum plasma concentration of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
AUC from zero to infinity or last measurable concentration of sertraline after dose of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
JZoloftACTIVE_COMPARATOROral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions
ODT without waterEXPERIMENTALsertraline ODT 50 mg without water as a single oral dose under fasted conditions
ODT with waterEXPERIMENTALsertraline ODT 50 mg with water as a single oral dose under fasted conditions

Interventions

NameTypeDescription
JZoloftDRUG50 mg tablet on Day 1 of each period
sertraline ODTDRUG50 mg tablet on Day 1 of each period
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese subjects between the ages of 20 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious ...

Countries:Japan
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