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Albuterol

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Albuterol · 3 trials · 1 indication

Phase 1 3
NCT00730197Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mgHealthy
COMPLETED48 Analytics
NCT00649779Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mgHealthy
COMPLETED21 Analytics
NCT00649987Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mgHealthy
COMPLETED21 Analytics
PHASE1COMPLETED
Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNISOLDIPINE EXTENDED-RELEASE TABLETS, 40 MG
2ACTIVE_COMPARATORSular® Extended Release 40 mg tablets

Interventions

NameTypeDescription
Albuterol Sulfate Extended-Release Tablets 8 mgDRUG8mg, single dose fed
VoSpire® ER Tablets 8 mgDRUG8mg, single dose fed
albuterol sulfate extended-release 8 mg tabletsDRUG8mg, single dose fasting
VoSpire™ ER 8 mg tabletsDRUG8mg, single dose fasting
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Eligibility Criteria

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

I. Inclusion Criteria: Subjects who met the following criteria were included in the study. 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test perfor...

Countries:United States
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