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NCT01342198 Clinical Trial

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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01342198
Other study ID # A0081197
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2011
Est. completion date July 2011

Study information
Verified date July 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
• Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
• erythromycin
A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the curve from 0 to infinity (AUCinf) 3 days
Primary Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin 3 days
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 3 days
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