| An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
|
| An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes As Compared To The Immediate Release Formulation
|
| The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.
|
| 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
|
| Interventional
|
| Phase 1
|
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|
| Healthy
|
- Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch
- Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch
- Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch
- Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered fasted
|
- Experimental: Pregabalin controlled release, 330 mg, 400 to 500 calories
Intervention: Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
- Experimental: Pregabalin controlled release, 330 mg, 600 to 750 calories
Intervention: Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
- Experimental: Pregabalin controlled release, 330 mg, 800 to 1000 calories
Intervention: Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
- Pregabalin immediate release, 300 mg
Reference
Intervention: Drug: Pregabalin immediate release, 300 mg
|
|
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.
|
| |
| Completed
|
| 28
|
|
Same as current
|
| April 2011
|
| April 2011 (Final data collection date for primary outcome measure)
|
|
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
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 55 Years (Adult)
|
| Yes
|
|
Contact information is only displayed when the study is recruiting subjects
|
| United States
|
|
|
| |
| NCT01270815
|
| A0081188
|
| No
|
| Not Provided
|
| Not Provided
|
| Director, Clinical Trial Disclosure Group, Pfizer, Inc.
|
| Pfizer
|
| Not Provided
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer
|
| May 2011
|
