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Completed

NCT Number: NCT01342198

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin controlled release, 330 mg

Drug

A single oral dose of 330 mg controlled release tablet

Erythromycin

Drug

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

Primary outcomes

  1. Area under the curve from 0 to infinity (AUCinf)

    Time frame: 3 days

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

    Time frame: 3 days

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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