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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release Formulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 330 mg pregabalin controlled release: 400 to 500 calories
Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
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
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
Experimental: 330 mg pregabalin controlled release: 600 to 750 calories
Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
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
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
Experimental: 330 mg pregabalin controlled release: 800 to 1000 calories
Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
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
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
Other: 300 mg pregabalin immediate release
Drug: 300 mg pregabalin immediate release
A single dose of 300 mg immediate release capsule will be administered in the fasted state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, vital signs, and clinical safety laboratories.
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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