Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf) | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, and clinical safety laboratories. | 3 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25078976 | Derived | Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 330 mg pregabalin controlled release | Drug | A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal |
|
| 330 mg pregabalin controlled release | Drug | A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal |
|
| 300 mg pregabalin immediate release | Drug | A single dose of 300 mg immediate release capsule will be administered in the fasted state |
|
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided