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IVIb

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

IVIb · 1 trial · 1 indication

Phase 1 1
NCT00867880Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult SubjectsHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects
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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 to 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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Frequently asked questions about IVIb

What is IVIb?

IVIb is an investigational small molecule drug being developed by Cumberland Pharmaceuticals Inc. (CPIX). It is currently in Phase 1 clinical development. The drug is being studied for use in healthy subjects, according to clinical trial data.

What is IVIb used for?

IVIb is being studied for use in healthy subjects. It is currently in Phase 1 clinical development, with a completed pharmacokinetic study in healthy adult volunteers. The drug's specific therapeutic indication has not been established beyond this early-stage research.

Who makes IVIb?

IVIb is being developed by Cumberland Pharmaceuticals Inc., a company traded on the NASDAQ under the ticker symbol CPIX. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy subjects.

What phase is IVIb in?

IVIb is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a pharmacokinetic study in healthy adult subjects. The drug is still investigational and has not been approved for any use.

What clinical trials is IVIb in?

IVIb has one completed clinical trial, NCT00867880, titled "Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects." This Phase 1 study enrolled 12 healthy volunteers in Australia and was completed.