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Lansoprazole

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Dec 8, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment156

FDA Designations

No designations recorded

Clinical trial landscape

Lansoprazole · 3 trials · 1 indication

Phase 1 3
NCT01045967Lansoprazole 30 mg DR Capsule Fasting StudyHealthy
COMPLETED56 Analytics
NCT01046253Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle StudyHealthy
COMPLETED50 Analytics
NCT01046084Lansoprazole 30 mg DR Capsule Replicate Food StudyHealthy
COMPLETED50 Analytics
PHASE1COMPLETED
Lansoprazole 30 mg DR Capsule Fasting Study
Healthy
NCT0104596756
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PHASE1COMPLETED
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
Healthy
NCT0104625350
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PHASE1COMPLETED
Lansoprazole 30 mg DR Capsule Replicate Food Study
Healthy
NCT0104608450
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Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 12 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 12 hour period.

Bioequivalence based on AUC0-t.

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

Bioequivalence based on AUC0-inf.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Invesigational Test ProductEXPERIMENTALLansoprazole 30 mg delayed-release Capsules
Reference Listed DrugACTIVE_COMPARATORPrevacid® 30 mg delayed-release Capsules
Investigational Test ProductEXPERIMENTALLansoprazole 30 mg Delayed-Release Capsule

Interventions

NameTypeDescription
LansoprazoleDRUG30 mg delayed-release Capsule
Prevacid®DRUG30 mg delayed-release Capsule
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Eligibility Criteria

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

Inclusion Criteria: * Non-smokers or light smokers (10 or less cigarettes per day) * 18 years of age or older * Body Mass Index of 30 or less * Males or non-pregnant females * Normal clinical laboratory test results Exclusion Criteria: * Subjects with a significant history of chronic alcohol cons...

Countries:United States
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