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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pregabalin controlled release, 330 mg
* Drug: Pregabalin controlled release, 330 mg
* Drug: erythromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single Dose Pregabalin Controlled Release | Drug: Pregabalin controlled release, 330 mg<br>* A single oral dose of 330 mg controlled release tablet<br>|
| Experimental: 2<br>Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin | Drug: Pregabalin controlled release, 330 mg<br>* A single oral dose of 330 mg controlled release tablet<br>Drug: erythromycin<br>* A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve from 0 to infinity (AUCinf) |  | 3 days | 
| Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin, pharmacokinetics, bioavailability, bioequivalence