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An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01342198
First received: April 21, 2011
Last updated: July 27, 2011
Last verified: July 2011
History of Changes

April 21, 2011
July 27, 2011
June 2011
July 2011   (final data collection date for primary outcome measure)
  • Area under the curve from 0 to infinity (AUCinf) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01342198 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
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

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.

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01342198
A0081197
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

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