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
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
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJanuary 22, 2021
May 1, 2011
3 months
February 7, 2011
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
3 days
Secondary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
3 days
Study Arms (4)
Pregabalin controlled release, 330 mg, 400-500 calorie
EXPERIMENTALPregabalin controlled release, 330 mg, 600- 750 calorie
EXPERIMENTALPregabalin controlled release, 330 mg, bedtime
EXPERIMENTALPregabalin immediate release, 300 mg
OTHERReference Treatment
Interventions
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
A single oral dose of 330 mg controlled release tablet administered at bedtime
A single oral dose of 300 mg immediate release capsule administered in the evening
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Illicit drug use
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Publications (1)
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.
PMID: 25078976DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2011
First Posted
February 8, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 22, 2021
Record last verified: 2011-05