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Olanzapine OD

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 5, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Olanzapine OD · 2 trials · 2 indications

Phase 1 2
NCT01503437Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting ConditionFasting
COMPLETED22 Analytics
NCT01503450Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed ConditionFed
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition
Fasting
NCT0150343722
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PHASE1COMPLETED
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
Fed
NCT0150345026
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Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Olanzapine OD Tablets 5 mgEXPERIMENTALOlanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited
Zyprexa Zydis 5 mg TabletsACTIVE_COMPARATORZyprexa Zydis 5 mg Tablets of Cardinal Health, UK

Interventions

NameTypeDescription
Olanzapine OD Tablets 5 mgDRUGOlanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years * Non-smokers since at least six months * Willingness to provide written informed consent to participate in the study * Body-mass index of ≥18.5 kg/m2 and ≤ 24.9 kg/m2, with body weight not less than 50 kg * Absence...

Countries:India
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