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Nadolol/Bendroflumethiazide

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 23, 2024

Nadolol/Bendroflumethiazide target and mechanism

Molecular targetADRB1, ADRB2
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Nadolol/Bendroflumethiazide clinical trials

Nadolol/Bendroflumethiazide · 2 trials · 1 indication

Phase 1 2
NCT00648297Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mgHealthy
COMPLETED42 Analytics
NCT00647660Fasting Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mgHealthy
COMPLETED66 Analytics
PHASE1COMPLETED
Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNadolol/Bendroflumethiazide Tablets 80 mg/5 mg
2ACTIVE_COMPARATORCorzide® Tablets 80 mg/5 mg

Interventions

NameTypeDescription
Nadolol/Bendroflumethiazide Tablets 80 mg/5 mgDRUG80/5mg, single dose fed
Corzide® Tablets 80 mg/5 mgDRUG80/5mg, single dose fed
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Eligibility Criteria

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

Inclusion Criteria: 1. Age: 18 years and older 2. Sex: Male and/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (β-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the evening...

Countries:United States
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Frequently asked questions about Nadolol/Bendroflumethiazide

What is Nadolol/Bendroflumethiazide?

Nadolol/Bendroflumethiazide is a fixed-dose combination small molecule product containing the beta-adrenergic antagonist nadolol and the thiazide diuretic bendroflumethiazide. It is being developed by Viatris Inc. (ticker VTRS) as Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and is currently in Phase 1 clinical development.

What does Nadolol/Bendroflumethiazide target?

Nadolol/Bendroflumethiazide targets the beta-1 and beta-2 adrenergic receptors, known as ADRB1 and ADRB2. The nadolol component acts as an antagonist at these receptors, while bendroflumethiazide is a thiazide-type diuretic. This dual mechanism combines beta-blockade with diuretic activity in a single tablet formulation.

Who makes Nadolol/Bendroflumethiazide?

Nadolol/Bendroflumethiazide is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the clinical studies evaluating this fixed-dose combination product.

What phase is Nadolol/Bendroflumethiazide in?

Nadolol/Bendroflumethiazide is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies that have been completed, and no trials are currently active. The program has enrolled a total of 108 participants across its studies to date.

What clinical trials is Nadolol/Bendroflumethiazide in?

Nadolol/Bendroflumethiazide has been evaluated in two completed Phase 1 trials: NCT00648297, a fed study with 42 participants, and NCT00647660, a fasting study with 66 participants. Both compared Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg with Corzide Tablets 80 mg/5 mg in healthy volunteers in the United States.