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Prevacid

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

Prevacid · 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
HealthyUnlock trial analytics
PHASE1COMPLETED
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
HealthyUnlock trial analytics
PHASE1COMPLETED
Lansoprazole 30 mg DR Capsule Replicate Food Study
HealthyUnlock trial analytics

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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Frequently asked questions about Prevacid

What is Prevacid used for?

Prevacid is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical trials for use in healthy volunteers. The drug is being studied in three completed trials with a total enrollment of 156 participants.

Who makes Prevacid?

Prevacid is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The drug is currently in Phase 1 clinical development, with all three of its trials completed.

What phase is Prevacid in?

Prevacid is in Phase 1 clinical development. All three of its trials have been completed, with a total enrollment of 156 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Prevacid in?

Prevacid has been studied in three completed Phase 1 trials: NCT01045967 (Lansoprazole 30 mg DR Capsule Fasting Study), NCT01046084 (Lansoprazole 30 mg DR Capsule Replicate Food Study), and NCT01046253 (Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study). All trials enrolled healthy adults aged 18 years and older in the United States.

Is Prevacid the same as lansoprazole?

Prevacid is the brand name for lansoprazole, as indicated by the clinical trial titles that reference lansoprazole 30 mg DR capsules. The drug is being studied in healthy volunteers to evaluate its pharmacokinetic profile.