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Trial record 1 of 1 for:    NCT01009541
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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

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ClinicalTrials.gov Identifier: NCT01009541
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Last Update Posted Date December 29, 2009
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
  • Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ [ Time Frame: 5 days ]
  • Minimum plasma concentration at steady-state within a dosing interval (Cmin) [ Time Frame: 5 days ]
  • Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax) [ Time Frame: 5 days ]
  • The average plasma concentration at steady-state (Cav), half-life [ Time Frame: 5 days ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01009541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
Safety endpoints include evaluation of adverse events. [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
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, 82.5 mg
    82.5 mg controlled release tablet administered once daily for three days.
  • Drug: Pregabalin controlled release, 165 mg
    165 mg controlled release tablet administered once daily for three days.
  • Drug: Pregabalin controlled release, 330 mg
    330 mg controlled release tablet administered once daily for three days.
  • Drug: Pregabalin immediate release, 150 mg
    150 mg immediate release capsules administered every 12 hours for three days
Study Arms  ICMJE
  • Experimental: Pregabalin controlled release, 82.5 mg
    Intervention: Drug: Pregabalin controlled release, 82.5 mg
  • 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 * Not Provided

*   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: November 5, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (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 NCT01009541
Other Study ID Numbers  ICMJE A0081225
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 Center Pfizer
PRS Account Pfizer
Verification Date December 2009

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