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Inderal LA

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00647608Food Study of Propranolol Hydrochloride Extended-Release Capsules 160 mg and Inderal® LA Capsules 160 mgPHASE1 COMPLETED 98Sep 1, 2005Oct 1, 2005Apr 24, 20241 United States
NCT00647816Fasting Study of Propranolol Hydrochloride Extended-Release Capsules 160 mg and Inderal® LA Capsules 160 mgPHASE1 COMPLETED 100Sep 1, 2005Sep 1, 2005Apr 24, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPropranolol Hydrochloride Extended-Release Capsules 160 mg
2ACTIVE_COMPARATORInderal® LA Capsules 160 mg
Interventions
NameTypeDescription
Propranolol Hydrochloride Extended-Release Capsules 160 mgDRUG160mg, single dose fed
Inderal® LA Capsules 160 mgDRUG160mg, single dose fed
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Eligibility Criteria
Age Range18 Years — 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 a negative serum (Beta HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administ...

Countries:United States
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