An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

NCT ID: NCT01009541

Last Updated: 2021-01-22

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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

82.5 mg controlled release tablet administered once daily for three 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 three days.

Pregabalin controlled release, 330 mg

Group Type EXPERIMENTAL

Pregabalin controlled release, 330 mg

Intervention Type DRUG

330 mg controlled release tablet administered once daily for three days.

Pregabalin immediate release, 150 mg

Reference Treatment

Group Type OTHER

Pregabalin immediate release, 150 mg

Intervention Type DRUG

150 mg immediate release capsules administered every 12 hours for three days

Interventions

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Pregabalin controlled release, 82.5 mg

82.5 mg controlled release tablet administered once daily for three days.

Intervention Type DRUG

Pregabalin controlled release, 165 mg

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

Intervention Type DRUG

Pregabalin controlled release, 330 mg

330 mg controlled release tablet administered once daily for three days.

Intervention Type DRUG

Pregabalin immediate release, 150 mg

150 mg immediate release capsules administered every 12 hours for three 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

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

Other Identifiers

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A0081225

Identifier Type: -

Identifier Source: org_study_id

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