An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg And 165 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 75 Mg Of The Immediate Release Formulation Administered Twice Daily
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses 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 Nov 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 22, 2021
January 1, 2011
2 months
October 4, 2010
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 165 mg CR and 75 mg IR (total daily dose 150 mg)
5 days
AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 82.5 mg CR (two tablets administered concurrently) and 165 mg CR
5 days
Secondary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
5 days
Study Arms (3)
Pregabalin controlled release, 82.5 mg
EXPERIMENTALPregabalin controlled release, 165 mg
EXPERIMENTALPregabalin immediate release, 75mg
OTHERReference Treatment
Interventions
Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.
165 mg controlled release tablet administered once daily for four days.
75 mg immediate release capsule administered every 12 hours for four days
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
Brussels, B-1070, Belgium
Related Publications (1)
Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.
PMID: 25078977DERIVED
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
October 4, 2010
First Posted
October 13, 2010
Study Start
November 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 22, 2021
Record last verified: 2011-01