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The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin controlled release, 82.5 mg | Experimental |
| |
| Pregabalin controlled release, 165 mg | Experimental |
| |
| Pregabalin immediate release, 75mg | Other | Reference Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin controlled release, 82.5 mg | Drug | Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 165 mg CR and 75 mg IR (total daily dose 150 mg) | 5 days | |
| AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 82.5 mg CR (two tablets administered concurrently) and 165 mg CR | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 5 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 | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25078977 | Derived | Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
|
| 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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