A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.

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Detailed Description

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To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.

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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330 mg pregabalin controlled release: 400 to 500 calories

Group Type EXPERIMENTAL

330 mg pregabalin controlled release

Intervention Type DRUG

A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal

330 mg pregabalin controlled release: 600 to 750 calories

Group Type EXPERIMENTAL

330 mg pregabalin controlled release

Intervention Type DRUG

A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal

330 mg pregabalin controlled release: 800 to 1000 calories

Group Type EXPERIMENTAL

330 mg pregabalin controlled release

Intervention Type DRUG

A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal

300 mg pregabalin immediate release

Group Type OTHER

300 mg pregabalin immediate release

Intervention Type DRUG

A single dose of 300 mg immediate release capsule will be administered in the fasted state

Interventions

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330 mg pregabalin controlled release

A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal

Intervention Type DRUG

330 mg pregabalin controlled release

A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal

Intervention Type DRUG

330 mg pregabalin controlled release

A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal

Intervention Type DRUG

300 mg pregabalin immediate release

A single dose of 300 mg immediate release capsule will be administered in the fasted state

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