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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pregabalin controlled release, 330 mg (Drug); Pregabalin controlled release, 330 mg (Drug); erythromycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Area under the curve from 0 to infinity (AUCinf)

Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin

Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

Pfizer Investigational Site, Bruxelles B-1070, Belgium
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2011
Last updated: July 27, 2011

Page last updated: August 23, 2015

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