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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01342198

Enrollment

Registered

2011-04-27

Start date

2011-06-30

Completion date

2011-07-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pregabalin, pharmacokinetics, bioavailability, bioequivalence

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

Interventions

DRUGPregabalin controlled release, 330 mg

A single oral dose of 330 mg controlled release tablet

DRUGerythromycin

A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the curve from 0 to infinity (AUCinf)	3 days
Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin	3 days

Secondary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026