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Olmesartan Medoxomil

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Olmesartan Medoxomil · 2 trials · 1 indication

Phase 1 2
NCT00648219Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mgHealthy
COMPLETED36 Analytics
NCT00649623Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mgHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collections through 48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOlmesartan Medoxomil Tablets 40 mg
2ACTIVE_COMPARATORBenicar® Tablets 40 mg

Interventions

NameTypeDescription
Olmesartan Medoxomil Tablets 40 mgDRUG40mg, single dose fed
Benicar® Tablets 40 mgDRUG40mg, single dose fed
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Eligibility Criteria

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

Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...

Countries:United States
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Frequently asked questions about Olmesartan Medoxomil

What is Olmesartan Medoxomil used for?

Olmesartan Medoxomil is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetic profile. The drug is being developed by Viatris Inc. and has not been approved for any indication.

Who makes Olmesartan Medoxomil?

Olmesartan Medoxomil is being developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers. Viatris is responsible for the ongoing clinical program for this investigational small molecule.

What phase is Olmesartan Medoxomil in?

Olmesartan Medoxomil is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers in the United States. The drug remains investigational and has not received regulatory approval. Viatris Inc. is the developer of this small molecule.

What clinical trials is Olmesartan Medoxomil in?

Olmesartan Medoxomil has two completed Phase 1 clinical trials. NCT00648219 is a fed study comparing Olmesartan Medoxomil tablets 40 mg to Benicar tablets 40 mg, enrolling 36 healthy volunteers. NCT00649623 is a fasting study with the same design, also enrolling 36 healthy volunteers. Both trials were conducted in the United States.

Is Olmesartan Medoxomil the same as Benicar?

Olmesartan Medoxomil is being studied as a potential generic equivalent to Benicar. The Phase 1 clinical trials compare Olmesartan Medoxomil tablets 40 mg directly against Benicar tablets 40 mg under both fed and fasting conditions. However, Olmesartan Medoxomil remains an investigational drug and is not yet approved.

How does Olmesartan Medoxomil work?

Olmesartan Medoxomil is a small molecule being developed by Viatris Inc. The mechanism of action has not been disclosed in the available clinical trial information. The drug is currently in Phase 1 development, with completed studies evaluating its pharmacokinetics in healthy volunteers compared to a reference product.