Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01321671
First received: March 22, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.


Condition Intervention Phase
Healthy
Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie
Drug: Pregabalin controlled release, 330 mg, fasted
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: The Pharmacokinetics Of Pregabalin Controlled Release Formulation In Fed State Compared To The Controlled Release And Immediate Release Formulations In The Fasted State

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the curve from 0 to infinity (AUCinf) and peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) fed and CR fasted [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatment [ 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: 24
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin controlled release, 330 mg, 600- 750 calorie 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
Experimental: Pregabalin controlled release, 330 mg, fasted Drug: Pregabalin controlled release, 330 mg, fasted
A single oral dose of 330 mg controlled release tablet administered fasted in the evening
Pregabalin immediate release, 300 mg Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered in the evening

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: NCT01321671

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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: NCT01321671     History of Changes
Other Study ID Numbers: A0081228
Study First Received: March 22, 2011
Last Updated: June 30, 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 21, 2014