You are here

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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
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.
Show details

- 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.
Show details

- Illicit drug use

- Pregnant or nursing females

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

NCT01342198
Pfizer
Completed
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

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
Intervention Model: Crossover Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01342198
A0081197
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now