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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pregabalin controlled release, 330 mg; Drug: erythromycin

• Registration Number: NCT01342198
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-27
• Study Start: 2011-06
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Pregabalin controlled release, 330 mg	Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
1	Pregabalin controlled release, 330 mg	Single Dose Pregabalin Controlled Release
2	erythromycin	Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium