NCT01342198

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin controlled release, 330 mg	A single oral dose of 330 mg controlled release tablet
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-04-27
• Last updated: 2021-01-22

Locations

1 site across 1 country: Belgium