An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule

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NCT01202422

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Study Location
Pfizer Investigational Site
Bruxelles, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Illicit drug use


- Pregnant or nursing females


- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
Official Title  ICMJE An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 165 Mg And 330 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 150 Mg Of The Immediate Release Formulation Administered Twice Daily
Brief Summary The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two 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 two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
Detailed Description Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Pregabalin controlled release, 165 mg
    Two tablets of 165 mg controlled release (administered concurrently) once daily for four days.
  • Drug: Pregabalin controlled release, 330 mg
    330 mg controlled release tablet administered once daily for four days.
  • Drug: Pregabalin immediate release, 150 mg
    150 mg immediate release capsules administered every 12 hours for four days
Study Arms  ICMJE
  • Experimental: Pregabalin controlled release, 165 mg
    Intervention: Drug: Pregabalin controlled release, 165 mg
  • Experimental: Pregabalin controlled release, 330 mg
    Intervention: Drug: Pregabalin controlled release, 330 mg
  • Pregabalin immediate release, 150 mg
    Reference Treatment
    Intervention: Drug: Pregabalin immediate release, 150 mg
Publications * Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2010)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01202422
Other Study ID Numbers  ICMJE A0081198
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP