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Hyzaar

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01149486Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting ConditionsPHASE1 COMPLETED 20 — — Jan 1, 2004Feb 1, 2004Dec 8, 20101 United States
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Study Endpoints
Primary Endpoints
Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.

Bioequivalence based on Losartan Cmax.

AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 48 hour period.

Bioequivalence based on Losartan AUC0-t.

AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 48 hour period.

Bioequivalence based on Losartan AUC0-inf.

Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide Cmax.

AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide AUC0-t.

AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide AUC0-inf.

Secondary Endpoints
Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.
AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 48 hour period.
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 48 hour period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Generic Test ProductEXPERIMENTALLosartan potassium/Hydrochlorothiazide 100/25 mg Tablets
Reference Listed DrugACTIVE_COMPARATORHyzaar® 100/25 mg Tablets
Interventions
NameTypeDescription
Losartan potassium/HydrochlorothiazideDRUG100/25 mg Tablets
Hyzaar®DRUG100/25 mg Tablets
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women, 18-45 years of age (inclusive). * Body mass index should be less than or equal to 30 * Screening procedures completed within 28 days prior to dosing. * If female and: * of child bearing potential, is practicing an acceptable barrier method of birth co...

Countries:United States
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