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The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin controlled release, 330 mg, 400-500 calorie | Experimental |
| |
| Pregabalin controlled release, 330 mg, 600- 750 calorie | Experimental |
| |
| Pregabalin controlled release, 330 mg, bedtime | Experimental |
| |
| Pregabalin immediate release, 300 mg | Other | Reference Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| 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, bedtime | Drug | A single oral dose of 330 mg controlled release tablet administered at bedtime |
|
| Pregabalin immediate release, 300 mg | Drug | A single oral dose of 300 mg immediate release capsule administered in the evening |
|
| 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 |
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