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Nadolol/Bendroflumethiazide

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Nadolol/Bendroflumethiazide is a combination small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating the fasting and fed state pharmacokinetics of the 80 mg/5 mg tablet formulation. The drug is being developed by Viatris Inc. (VTRS).

Who makes Nadolol/Bendroflumethiazide?

Nadolol/Bendroflumethiazide is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetic profile in healthy adult volunteers.

What phase is Nadolol/Bendroflumethiazide in?

Nadolol/Bendroflumethiazide is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Nadolol/Bendroflumethiazide in?

Nadolol/Bendroflumethiazide has two completed Phase 1 trials. NCT00647660 is a fasting study comparing the 80 mg/5 mg tablet to Corzide tablets, enrolling 66 participants. NCT00648297 is a fed study with the same comparison, enrolling 42 participants. Both were conducted in the United States.

Is Nadolol/Bendroflumethiazide the same as Corzide?

Nadolol/Bendroflumethiazide is being studied as a generic equivalent to Corzide tablets. The Phase 1 trials compare the pharmacokinetics of the 80 mg/5 mg Nadolol/Bendroflumethiazide tablet to Corzide 80 mg/5 mg tablets in healthy volunteers under fasting and fed conditions.