An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

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Detailed Description

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Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release 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, 82.5 mg

Group Type EXPERIMENTAL

Pregabalin controlled release, 82.5 mg

Intervention Type DRUG

Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.

Pregabalin controlled release, 165 mg

Group Type EXPERIMENTAL

Pregabalin controlled release, 165 mg

Intervention Type DRUG

165 mg controlled release tablet administered once daily for four days.

Pregabalin immediate release, 75mg

Reference Treatment

Group Type OTHER

Pregabalin immediate release, 75mg

Intervention Type DRUG

75 mg immediate release capsule administered every 12 hours for four days

Interventions

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Pregabalin controlled release, 82.5 mg

Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.

Intervention Type DRUG

Pregabalin controlled release, 165 mg

165 mg controlled release tablet administered once daily for four days.

Intervention Type DRUG

Pregabalin immediate release, 75mg

75 mg immediate release capsule administered every 12 hours for four days

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