An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-04-30

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 following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

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Detailed Description

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Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pregabalin controlled release, 330 mg, 400 to 500 calories

Group Type EXPERIMENTAL

Pregabalin controlled release, 330 mg, 400 to 500 calories

Intervention Type DRUG

A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch

Pregabalin controlled release, 330 mg, 600 to 750 calories

Group Type EXPERIMENTAL

Pregabalin controlled release, 330 mg, 600 to 750 calories

Intervention Type DRUG

A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch

Pregabalin controlled release, 330 mg, 800 to 1000 calories

Group Type EXPERIMENTAL

Pregabalin controlled release, 330 mg, 800 to 1000 calories

Intervention Type DRUG

A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch

Pregabalin immediate release, 300 mg

Reference

Group Type OTHER

Pregabalin immediate release, 300 mg

Intervention Type DRUG

A single oral dose of 300 mg immediate release capsule administered fasted

Interventions

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Pregabalin controlled release, 330 mg, 400 to 500 calories

A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch

Intervention Type DRUG

Pregabalin controlled release, 330 mg, 600 to 750 calories

A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch

Intervention Type DRUG

Pregabalin controlled release, 330 mg, 800 to 1000 calories

A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch

Intervention Type DRUG

Pregabalin immediate release, 300 mg

A single oral dose of 300 mg immediate release capsule administered fasted

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes