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The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three 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 three pregabalin controlled release tablets as compared to multiple doses of the 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 controlled release, 330 mg | Experimental |
| |
| Pregabalin immediate release, 150 mg | Other | Reference Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin controlled release, 82.5 mg | Drug | 82.5 mg controlled release tablet administered once daily for three days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve at steady-state for a dosing interval (AUCÏ„), Dose-adjusted AUCÏ„ | 5 days | |
| Minimum plasma concentration at steady-state within a dosing interval (Cmin) | 5 days | |
| Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax) | 5 days | |
| The average plasma concentration at steady-state (Cav), half-life | 5 days | |
| Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include evaluation of adverse events. | 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 | 1070 | Belgium |
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| 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 three days. |
|
| Pregabalin controlled release, 330 mg | Drug | 330 mg controlled release tablet administered once daily for three days. |
|
| Pregabalin immediate release, 150 mg | Drug | 150 mg immediate release capsules administered every 12 hours for three 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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