An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01009541
First received: November 5, 2009
Last updated: December 28, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three 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 three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.


Condition Intervention Phase
Healthy
Drug: Pregabalin controlled release, 82.5 mg
Drug: Pregabalin controlled release, 165 mg
Drug: Pregabalin controlled release, 330 mg
Drug: Pregabalin immediate release, 150 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, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal 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 at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Minimum plasma concentration at steady-state within a dosing interval (Cmin) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • The average plasma concentration at steady-state (Cav), half-life [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety endpoints include evaluation of adverse events. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin controlled release, 82.5 mg Drug: Pregabalin controlled release, 82.5 mg
82.5 mg controlled release tablet administered once daily for three days.
Experimental: Pregabalin controlled release, 165 mg Drug: Pregabalin controlled release, 165 mg
165 mg controlled release tablet administered once daily for three days.
Experimental: Pregabalin controlled release, 330 mg Drug: Pregabalin controlled release, 330 mg
330 mg controlled release tablet administered once daily for three days.
Pregabalin immediate release, 150 mg
Reference Treatment
Drug: Pregabalin immediate release, 150 mg
150 mg immediate release capsules administered every 12 hours for three days

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009541

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
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: NCT01009541     History of Changes
Other Study ID Numbers: A0081225
Study First Received: November 5, 2009
Last Updated: December 28, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
pregabalin pharmacokinetics bioavailability bioequivalence

Additional relevant MeSH terms:
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014