An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.

Key facts

Study ID

NCT01257529

Run by

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

People needed

28

Starts

2011-03-01

Expected to finish

2011-04-01

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Illicit drug use
• Pregnant or nursing females
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Where it is running

• Pfizer Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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