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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

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.
 
ClinicalTrials.gov Identifier: NCT01009541
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ [ Time Frame: 5 days ]
  2. Minimum plasma concentration at steady-state within a dosing interval (Cmin) [ Time Frame: 5 days ]
  3. Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax) [ Time Frame: 5 days ]
  4. The average plasma concentration at steady-state (Cav), half-life [ Time Frame: 5 days ]
  5. 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 ]

Secondary Outcome Measures :
  1. Safety endpoints include evaluation of adverse events. [ Time Frame: 5 days ]

Eligibility Criteria
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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
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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): NCT01009541


Locations
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Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT01009541    
Other Study ID Numbers: A0081225
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: December 2009
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
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