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Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01291524
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.

Condition or disease Intervention/treatment Phase
Healthy Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie Drug: Pregabalin controlled release, 330 mg, bedtime Drug: Pregabalin immediate release, 300 mg Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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 Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin controlled release, 330 mg, 400-500 calorie Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal

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, bedtime Drug: Pregabalin controlled release, 330 mg, bedtime
A single oral dose of 330 mg controlled release tablet administered at bedtime

Pregabalin immediate release, 300 mg
Reference Treatment
Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered in the evening




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days ]


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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

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): NCT01291524


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01291524     History of Changes
Other Study ID Numbers: A0081238
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011
Keywords provided by Pfizer:
pregabalin
pharmacokinetics
bioavailability
bioequivalence
Additional relevant MeSH terms:
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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
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs