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Also known as suspension IR
IR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 50 mg oral suspension | EXPERIMENTAL | once daily for one day |
| 50 mg CR Type 1 | EXPERIMENTAL | once daily for one day |
| 50 mg CR Type 2 | EXPERIMENTAL | once daily for one day |
| 50 mg SR Type 3 | EXPERIMENTAL | once daily for one day |
| Name | Type | Description |
|---|---|---|
| suspension IR | DRUG | 50 mg IR suspension once daily for one day |
| CR 1 | DRUG | 50 mg shorter release CR once daily for one day |
| CR 2 | DRUG | 50 mg medium release CR once daily for one day |
| CR 3 | DRUG | longer release SR formulation once daily for one day |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...
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IR is an immediate release small molecule formulation that Pfizer, Inc. (ticker PFE) studied for rheumatoid arthritis. It is an investigational product that has been tested in a Phase 1 clinical trial in healthy volunteers, not in patients with active disease. Pfizer has also studied controlled release formulations of the same compound.
IR was studied as a treatment for rheumatoid arthritis, an immunology condition. The only listed trial evaluated the immediate release formulation in normal healthy volunteers rather than in rheumatoid arthritis patients, so its use in the disease itself has not been established in the available clinical program.
Pfizer, Inc. (ticker PFE) is the developer of IR. The company sponsored the Phase 1 trial of the immediate release formulation and the related controlled release formulations. No other developer or partner is associated with the program in the available information.
IR is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study enrolled 16 participants and was conducted in the United States. IR has not been approved by the FDA and remains an investigational product.
IR has been evaluated in one completed Phase 1 trial, NCT00782600, titled Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers. The trial enrolled 16 healthy volunteers aged 18 years and older in the United States and used a controlled, randomized design without double blinding.
Yes, IR is also known as suspension IR. Both names refer to the same immediate release formulation developed by Pfizer, Inc. (ticker PFE) for rheumatoid arthritis. Searches using either name point to the same Phase 1 program and the same completed trial, NCT00782600.