Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pregabalin controlled release · 10 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Single Dose Pregabalin Controlled Release |
| 2 | EXPERIMENTAL | Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin |
| Pregabalin controlled release, 330 mg, 600- 750 calorie | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, fasted | EXPERIMENTAL | - |
| Pregabalin immediate release, 300 mg | OTHER | - |
| Pregabalin controlled release, 330 mg, low-fat | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, medium-fat | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, high-fat | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, 400 to 500 calories | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, 600 to 750 calories | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, 800 to 1000 calories | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, 400-500 calorie | EXPERIMENTAL | - |
| Pregabalin controlled release, 330 mg, bedtime | EXPERIMENTAL | - |
| Pregabalin controlled release, 82.5 mg | EXPERIMENTAL | - |
| Pregabalin controlled release, 165 mg | EXPERIMENTAL | - |
| Pregabalin immediate release, 75mg | OTHER | Reference Treatment |
| Pregabalin controlled release, 330 mg | EXPERIMENTAL | - |
| Pregabalin immediate release, 150 mg | OTHER | Reference Treatment |
| Pregabalin immediate release, 25 mg | OTHER | Reference Treatment |
| 330 mg pregabalin controlled release: 400 to 500 calories | EXPERIMENTAL | - |
| 330 mg pregabalin controlled release: 600 to 750 calories | EXPERIMENTAL | - |
| 330 mg pregabalin controlled release: 800 to 1000 calories | EXPERIMENTAL | - |
| 300 mg pregabalin immediate release | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Pregabalin controlled release, 330 mg | DRUG | A single oral dose of 330 mg controlled release tablet |
| erythromycin | DRUG | A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR |
| Pregabalin controlled release, 330 mg, 600- 750 calorie | DRUG | A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal |
| Pregabalin controlled release, 330 mg, fasted | DRUG | A single oral dose of 330 mg controlled release tablet administered fasted in the evening |
| Pregabalin immediate release, 300 mg | DRUG | A single oral dose of 300 mg immediate release capsule administered in the evening |
| Pregabalin controlled release, 330 mg, low-fat | DRUG | A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal |
| Pregabalin controlled release, 330 mg, medium-fat | DRUG | A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal |
| Pregabalin controlled release, 330 mg, high-fat | DRUG | A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal |
| Pregabalin controlled release, 330 mg, 400 to 500 calories | DRUG | A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch |
| Pregabalin controlled release, 330 mg, 600 to 750 calories | DRUG | A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch |
| Pregabalin controlled release, 330 mg, 800 to 1000 calories | DRUG | A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch |
| Pregabalin controlled release, 330 mg, 400 to 500 calorie | DRUG | A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal |
| Pregabalin controlled release, 330 mg, bedtime | DRUG | A single oral dose of 330 mg controlled release tablet administered at bedtime |
| Pregabalin controlled release, 82.5 mg | DRUG | Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days. |
| Pregabalin controlled release, 165 mg | DRUG | 165 mg controlled release tablet administered once daily for four days. |
| Pregabalin immediate release, 75mg | DRUG | 75 mg immediate release capsule administered every 12 hours for four days |
| Pregabalin immediate release, 150 mg | DRUG | 150 mg immediate release capsules administered every 12 hours for four days |
| Pregabalin immediate release, 25 mg | DRUG | 25 mg immediate release capsules administered three times daily for four days |
| 330 mg pregabalin controlled release | DRUG | A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal |
| 300 mg pregabalin immediate release | DRUG | A single dose of 300 mg immediate release capsule will be administered in the fasted state |
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 controlled release is an extended-release tablet formulation of pregabalin, a small molecule developed by Pfizer. It is designed to release the drug over time rather than immediately. The program is in Phase 1 clinical development, and the specific indication being studied has not been disclosed.
Pregabalin controlled release targets calcium channel subunits, specifically CACNA1H, CACNA2D1, CACNA1C, CACNA2D3, CACNA1S, and CACNA2D2. It acts as a modulator of these targets. This mechanism is consistent with the known pharmacology of pregabalin, which binds to the alpha-2-delta subunit of voltage-gated calcium channels.
Pregabalin controlled release is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical trials for this formulation.
Pregabalin controlled release is in Phase 1 clinical development. It is an investigational formulation and has not been approved by the FDA. All ten of its recorded trials are completed, and there are currently no active trials.
Pregabalin controlled release has been studied in ten completed Phase 1 trials, including NCT01342198, NCT01321671, NCT01291524, and NCT01270815. These trials enrolled healthy volunteers and investigated the pharmacokinetics and absorption of the controlled release tablet under various conditions, such as with food or other drugs.
Pregabalin controlled release is a distinct extended-release tablet formulation of pregabalin. It is also known by various descriptive names that include dosage strengths such as 82.5 mg, 165 mg, 330 mg, and 400 to 500 calorie or 600 to 750 calorie food conditions. These names refer to the same controlled release product.