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Trial record 1 of 1 for:    NCT01342198
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An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet

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ClinicalTrials.gov Identifier: NCT01342198
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : July 28, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 21, 2011
First Posted Date  ICMJE April 27, 2011
Last Update Posted Date July 28, 2011
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
  • Area under the curve from 0 to infinity (AUCinf) [ Time Frame: 3 days ]
  • Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 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 Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Cross-Over Study to Evaluate the Effects of Multiple Doses of Erythromycin on the Pharmacokinetics of a Single Dose of Pregabalin Controlled Release in Healthy Subjects
Brief Summary The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.
Detailed Description Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin
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, 330 mg
    A single oral dose of 330 mg controlled release tablet
  • Drug: erythromycin
    A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
Study Arms  ICMJE
  • Experimental: 1
    Single Dose Pregabalin Controlled Release
    Intervention: Drug: Pregabalin controlled release, 330 mg
  • Experimental: 2
    Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
    Interventions:
    • Drug: Pregabalin controlled release, 330 mg
    • Drug: erythromycin
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: April 25, 2011)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (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 NCT01342198
Other Study ID Numbers  ICMJE A0081197
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 July 2011

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