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IVIb · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IVIb | DRUG | 800mg 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 |
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...
IVIb is an investigational small molecule developed by Cumberland Pharmaceuticals Inc. under the ticker CPIX. It is an intravenous formulation studied in a Phase 1 pharmacokinetic trial in healthy adult subjects. The specific therapeutic indication for IVIb has not been publicly disclosed.
IVIb is being developed by Cumberland Pharmaceuticals Inc., which trades on the Nasdaq under the ticker CPIX. Cumberland is the sponsor of the clinical program for IVIb, including the completed Phase 1 pharmacokinetic study conducted in Australia.
IVIb is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has not been approved by the FDA and remains investigational.
IVIb has been evaluated in one completed Phase 1 trial, NCT00867880, titled a Pharmacokinetic Study of Ibuprofen Injection (IVIb) in Healthy Adult Subjects. The trial enrolled 12 healthy adults in Australia, was randomized, double blind, and used an active control.
Yes, IVIb is the shorthand name for Ibuprofen Injection, an intravenous formulation of ibuprofen. The completed Phase 1 pharmacokinetic study, NCT00867880, was conducted in healthy adult subjects to evaluate the injection formulation.