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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Pregabalin

Criteria

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