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Sertraline

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 11, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Sertraline · 2 trials · 1 indication

Phase 1 2
NCT01267383Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed ConditionsHealthy
COMPLETED32 Analytics
NCT01267396Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting ConditionsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions
Healthy
NCT0126738332
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PHASE1COMPLETED
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions
Healthy
NCT0126739632
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Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sertraline Hydrochloride tablets 100 mgEXPERIMENTALSertraline Hydrochloride tablets 100 mg of Dr.Reddy's Laboratories Limited
Zoloft 100 mg TabletsACTIVE_COMPARATORZoloft 100 mg Tablets of Pfizer

Interventions

NameTypeDescription
SertralineDRUGSertraline Hydrochloride Tablets 100 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy human subjects ages 18 and 45 years (including both). 2. Subjects weight within the normal range according to normal values for the body mass index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight. 3. Subjects with normal health as determined by personal medical hist...

Countries:India
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