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A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080612
First Posted: March 4, 2010
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.

Condition Intervention Phase
Healthy Drug: 330 mg pregabalin controlled release Drug: 300 mg pregabalin immediate release Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 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:
  • Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf) [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • Adverse events, vital signs, and clinical safety laboratories. [ Time Frame: 3 days ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 330 mg pregabalin controlled release: 400 to 500 calories Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
Experimental: 330 mg pregabalin controlled release: 600 to 750 calories Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
Experimental: 330 mg pregabalin controlled release: 800 to 1000 calories Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
300 mg pregabalin immediate release Drug: 300 mg pregabalin immediate release
A single dose of 300 mg immediate release capsule will be administered in the fasted state

Detailed Description:
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080612


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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01080612     History of Changes
Other Study ID Numbers: A0081239
First Submitted: February 26, 2010
First Posted: March 4, 2010
Last Update Posted: March 5, 2015
Last Verified: July 2010

Keywords provided by Pfizer:
pregabalin
pharmacokinetics
bioavailability

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs