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Cozaar

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

Cozaar · 2 trials · 1 indication

Phase 1 2
NCT01124162Losartan 100 mg Tablets in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED80 Analytics
NCT01124175Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting ConditionsHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions
Healthy
NCT0112416280
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PHASE1COMPLETED
Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions
Healthy
NCT0112417580
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Study Endpoints

Primary Endpoints

Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 24 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 24 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 24 hour period.

Bioequivalence based on Losartan AUC0-inf.

Secondary Endpoints

Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 24 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 24 hour period.
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 24 hour period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Generic Test ProductEXPERIMENTALLosartan 100mg Tablets
Reference Listed DrugACTIVE_COMPARATORCozaar® 100 mg Tablets

Interventions

NameTypeDescription
LosartanDRUG100 mg Tablet
Cozaar®DRUG100 mg Tablet
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Eligibility Criteria

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

Inclusion Criteria: * Non-child-bearing potential female or male. * Non-smoker. * 18 years of age and older. * Capable of consent. * Non-child-bearing potential female subject: * Post-menopausal state: absence of menses for 12 months prior to drug administration. * Surgically sterile: hysterec...

Countries:Canada
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Frequently asked questions about Cozaar

What is Cozaar?

Cozaar is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy subjects. The drug is being studied in two completed trials with a total enrollment of 160 participants.

What is Cozaar used for?

Cozaar is being studied for use in healthy subjects, as part of clinical trials evaluating the drug under fasting and non-fasting conditions. The trials are designed to assess the drug's effects in healthy volunteers, with no specific disease indication being targeted.

Who makes Cozaar?

Cozaar is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug in healthy subjects, with two Phase 1 studies completed.

What phase is Cozaar in?

Cozaar is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy subjects. The drug is still in the early stages of clinical testing and is not yet approved for any use.

What clinical trials is Cozaar in?

Cozaar has been studied in two completed Phase 1 trials: NCT01124162, titled "Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions," and NCT01124175, titled "Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions." Each trial enrolled 80 healthy subjects in Canada.

Is Cozaar the same as losartan?

Cozaar is a brand name for losartan, as indicated by the clinical trial titles that refer to losartan 100 mg tablets. The trials evaluate the drug under fasting and non-fasting conditions in healthy subjects, confirming that Cozaar and losartan refer to the same active ingredient.