| Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
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| An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
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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.
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| 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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| Interventional
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| Phase 1
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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| Healthy
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- Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
- Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie
A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
- Drug: Pregabalin controlled release, 330 mg, bedtime
A single oral dose of 330 mg controlled release tablet administered at bedtime
- Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered in the evening
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- Experimental: Pregabalin controlled release, 330 mg, 400-500 calorie
Intervention: Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie
- Experimental: Pregabalin controlled release, 330 mg, 600- 750 calorie
Intervention: Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie
- Experimental: Pregabalin controlled release, 330 mg, bedtime
Intervention: Drug: Pregabalin controlled release, 330 mg, bedtime
- Pregabalin immediate release, 300 mg
Reference Treatment
Intervention: Drug: Pregabalin immediate release, 300 mg
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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.
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| Completed
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| 24
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Same as current
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| May 2011
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| May 2011 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Healthy male or females
- Between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria:
- Illicit drug use
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
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| Sexes Eligible for Study: |
All |
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| 18 Years to 55 Years (Adult)
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| Yes
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Contact information is only displayed when the study is recruiting subjects
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| United States
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| NCT01291524
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| A0081238
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| No
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| Not Provided
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| Not Provided
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| Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| May 2011
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