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Hyzaar

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 Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Hyzaar · 1 trial · 1 indication

Phase 1 1
NCT01149486Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
Healthy
NCT0114948620
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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 to 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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Frequently asked questions about Hyzaar

What is Hyzaar used for?

Hyzaar is a combination tablet containing losartan potassium and hydrochlorothiazide. It has been studied in healthy subjects under fasting conditions. The drug is being developed by Teva Pharmaceutical Industries Limited as a small molecule product.

Who makes Hyzaar?

Hyzaar is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is a small molecule product that has been studied in a clinical trial involving healthy volunteers.

What phase is Hyzaar in?

Hyzaar is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy subjects. The drug is investigational and has not been approved by regulatory authorities based on the available information.

What clinical trials is Hyzaar in?

Hyzaar has been studied in one completed clinical trial, NCT01148686, titled "Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions." This Phase 1 trial enrolled 20 healthy participants in the United States.

Is Hyzaar the same as losartan potassium and hydrochlorothiazide?

Hyzaar is a combination product containing losartan potassium and hydrochlorothiazide. The clinical trial for Hyzaar specifically evaluated the 100/25 mg tablet strength of this combination in healthy subjects under fasting conditions.