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This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a 330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th period to to estimate and compare the % of dose absorbed versus time profile for the three CR prototype tablets and the CR reference tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
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| Sequence 2 | Experimental |
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| Sequence 3 | Experimental |
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| Sequence 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1 - Treatment A: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration-time curve from time zero extrapolated to infinite time (AUClast) | predose to 48hr post dose | |
| Area under plasma concentration-time profile from time zero to time of last quantifiable concentration (AUCinf) | predose to 48hr post dose | |
| Maximum observed concentration within dosing interval (Cmax) | predose to 48hr post dose | |
| Time for Cmax Tmax | predose to 48hr post dose | |
| Terminal half-life (t1/2) | predose to 48hr post dose | |
| Safety endpoints will be evaluated by comparing the incidence and severity of AEs for each of the formulations evaluated | predose to 48hr post dose |
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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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| Sequence 1 - Treatment B: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 1 - Treatment C:Controlled Release Pregabalin | Drug | 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 1 - Treatment D: Controlled Release Pregabalin | Drug | 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 1 - Treatment E: Immediate Release Pregabalin | Drug | 300 mg IR capsule administered in the evening in the fasted state. |
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| Sequence 2 - Treatment B: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 2 - Treatment D: Controlled Release Pregabalin | Drug | 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 2 - Treatment A: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 2 - Treatment C: Controlled Release Pregabalin | Drug | 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 2 - Treatment E: Immediate Release Pregabalin | Drug | 300 mg IR capsule administered in the evening in the fasted state. |
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| Sequence 3 - Treatment C: Controlled Release Pregabalin | Drug | 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 3 - Treatment A: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 3 - Treatment D: Controlled Release Pregabalin | Drug | 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 3 - Treatment B: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 3 - Treatment E: Immediate Release Pregabalin | Drug | 300 mg IR capsule administered in the evening in the fasted state. |
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| Sequence 4 - Treatment D: Controlled Release Pregabalin | Drug | 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 4 - Treatment C: Controlled Release Pregabalin | Drug | 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 4 - Treatment B: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 4 - Treatment A: Controlled Release Pregabalin | Drug | 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal. |
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| Sequence 4 - Treatment E: Immediate Release Pregabalin | Drug | 300 mg IR capsule administered in the evening in the fasted state. |
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