Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.

Key facts

Study ID

NCT01321671

Run by

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

People needed

24

Starts

2011-04-01

Expected to finish

2011-06-01

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 — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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