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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 tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single Dose Pregabalin Controlled Release |
|
| 2 | Experimental | Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin controlled release, 330 mg | Drug | A single oral dose of 330 mg controlled release tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from 0 to infinity (AUCinf) | 3 days | |
| Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin | 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 | Brussels | B-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, 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 |
|
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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