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An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches 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:
NCT01270815
First received: January 4, 2011
Last updated: May 12, 2011
Last verified: May 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 a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.


Condition Intervention Phase
Healthy
Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
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 Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes 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, 400 to 500 calories Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch
Experimental: Pregabalin controlled release, 330 mg, 600 to 750 calories Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch
Experimental: Pregabalin controlled release, 330 mg, 800 to 1000 calories Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch
Pregabalin immediate release, 300 mg
Reference
Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered fasted

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
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: NCT01270815

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: NCT01270815     History of Changes
Other Study ID Numbers: A0081188
Study First Received: January 4, 2011
Last Updated: May 12, 2011
Health Authority: United States: Food and Drug Administration

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 November 27, 2014