Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pregabalin immediate release · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Pregabalin immediate release, 300 mg | OTHER | Reference Treatment |
| Pregabalin controlled release, 330 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pregabalin immediate release, 300 mg | DRUG | 300 mg immediate release capsule administered twice daily for four days |
| Pregabalin controlled release, 330 mg | DRUG | Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days |
Inclusion Criteria: * Healthy male or females * Between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: * Illicit drug use * Pregnant or nursing females * Females of childbearing potential who are unwilling or unable to use an acceptable me...
Pregabalin immediate release is a small molecule drug developed by Pfizer, Inc. (NYSE: PFE). It is an immediate release formulation of pregabalin, which is also available in controlled release forms. The drug is currently in Phase 1 clinical development. Its specific indications are undisclosed.
Pregabalin immediate release targets several calcium channel subunits: CACNA1H, CACNA2D1, CACNA1C, CACNA2D3, CACNA1S, and CACNA2D2. It acts as a modulator of these targets. This mechanism is thought to contribute to its pharmacological effects.
Pregabalin immediate release is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is a global pharmaceutical company headquartered in the United States.
Pregabalin immediate release is in Phase 1 clinical development. It has not been approved by the FDA for any indication. The drug is still being evaluated in clinical trials to assess its safety and pharmacokinetics.
Pregabalin immediate release has been studied in one completed clinical trial: NCT01257516. This Phase 1 trial investigated the absorption and pharmacokinetics of multiple doses of a controlled release pregabalin tablet compared to multiple doses of the immediate release pregabalin capsule in healthy volunteers. The trial enrolled 18 participants in Belgium.
Pregabalin immediate release is one formulation of pregabalin. It is also known as pregabalin immediate release 25 mg, 75 mg, 150 mg, and 300 mg. These refer to different dosage strengths of the same immediate release formulation. Other formulations, such as controlled release, also exist.