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Cozaar

Phase 1

Healthy | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Nov 2, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

Cozaar · 1 trial · 1 indication

Phase 1 1
NCT03459911A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting ConditionsHealthy
COMPLETED66 Analytics
PHASE1COMPLETED
A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions
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Study Endpoints

Primary Endpoints

Pharmacokinetic parameter for losartan
10 Days

Peak Plasma Concentration (Cmax)

Secondary Endpoints

Safety and tolerability of investigational products
17 Days
Other pharmacokinetic parameters for losartan
10 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Losartan potassium 100 mg TabletsEXPERIMENTALLosartan potassium is the test product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Losartan potassium.
Cozaar® (Losartan potassium)100 mg TabletsACTIVE_COMPARATORCozaar® (Losartan potassium) is the reference product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Cozaar®.

Interventions

NameTypeDescription
Cozaar 100mg TabletDRUGCozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands)
Losartan potassium 100mgDRUGLosartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The following criteria should be checked at the time of study entry. If any does not apply at the time of study entry, the subject must not be included in the study: 1. Healthy adult human subjects, aged between 18 to 45 years (both inclusive). 2. Subjects with Body Mass Index ...

Countries:India
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Frequently asked questions about Cozaar

What is Cozaar?

Cozaar is a small molecule drug being developed by Ligand Pharmaceuticals Incorporated (ticker: LGND). It is currently in Phase 1 clinical development. The drug is being studied for use in healthy individuals, and its therapeutic area is classified as Other.

What is Cozaar used for?

Cozaar is being studied for use in healthy individuals. It is currently in Phase 1 clinical development. The drug is not approved for any specific disease or condition, and its therapeutic area is classified as Other.

Who makes Cozaar?

Cozaar is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker symbol LGND. The company is conducting clinical trials to evaluate the drug in healthy volunteers.

What phase is Cozaar in?

Cozaar is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety and pharmacokinetics.

What clinical trials is Cozaar in?

Cozaar has one completed Phase 1 clinical trial, identified as NCT03459911. This trial was a bioequivalence study of losartan potassium tablets (100 mg) in healthy adults under fasting conditions. The study was conducted in India with 66 participants.

Is Cozaar the same as losartan?

Cozaar is being studied as losartan potassium tablets. The clinical trial NCT03459911 evaluated losartan potassium 100 mg tablets. The drug is being developed by Ligand Pharmaceuticals Incorporated under the name Cozaar.