NCT01080612

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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
DRUG	300 mg pregabalin immediate release	A single dose of 300 mg immediate release capsule will be administered in the fasted state

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-03-04
• Last updated: 2021-01-29

Locations

1 site across 1 country: United States