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IVIb

Phase 1

Healthy | Small molecule | Other |Cumberland Pharmaceuticals Inc.|Last Updated: Dec 15, 2014

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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00867880Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult SubjectsPHASE1 COMPLETED 12Mar 1, 2009Jun 1, 2009Dec 15, 20141 Australia
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Study Endpoints
Primary Endpoints
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
12 hours
Secondary Endpoints
To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.
12 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
IVIbDRUG800mg IVIb diluted in 200mL NS will be given IV (in the vein) concurrently with an oral placebo on Day 1 and 200ml Normal Saline will be given IV (in the vein)concurrently with 800mg oral ibuprofen on Day 8
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers between the ages of 18 and 65 years (at the time of consent). Exclusion Criteria: * Participants lacking good venous access in both arms. * History of allergy or hypersensitivity to NSAIDs or any component of intravenous ibuprofen. * Have never taken aspir...

Countries:Australia
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