NCT01220219

An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers

An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg And 165 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 75 Mg Of The Immediate Release Formulation Administered Twice Daily

• 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 extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two 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 two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Detailed description

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin controlled release, 82.5 mg	Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.
DRUG	Pregabalin controlled release, 165 mg	165 mg controlled release tablet administered once daily for four days.
DRUG	Pregabalin immediate release, 75mg	75 mg immediate release capsule administered every 12 hours for four days

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-10-13
• Last updated: 2021-01-22

Locations

1 site across 1 country: Belgium