An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01257529
First received: December 8, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.


Condition Intervention Phase
Healthy
Drug: Pregabalin controlled release, 330 mg, low-fat
Drug: Pregabalin controlled release, 330 mg, medium-fat
Drug: Pregabalin controlled release, 330 mg, high-fat
Drug: Pregabalin immediate release, 300 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of A Low, Medium And High Fat Evening Meal On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin controlled release, 330 mg, low-fat Drug: Pregabalin controlled release, 330 mg, low-fat
A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal
Experimental: Pregabalin controlled release, 330 mg, medium-fat Drug: Pregabalin controlled release, 330 mg, medium-fat
A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal
Experimental: Pregabalin controlled release, 330 mg, high-fat Drug: Pregabalin controlled release, 330 mg, high-fat
A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal
Pregabalin immediate release, 300 mg
Reference Treatment
Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257529

Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01257529     History of Changes
Other Study ID Numbers: A0081227
Study First Received: December 8, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pregabalin
pharmacokinetics
bioavailability
bioequivalence

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 23, 2014