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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pregabalin immediate release, 300 mg; Drug: Pregabalin controlled release, 330 mg

• Registration Number: NCT01257516
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2011-02
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pregabalin immediate release, 300 mg	Pregabalin immediate release, 300 mg	Reference Treatment
Pregabalin controlled release, 330 mg	Pregabalin controlled release, 330 mg	-

Primary Outcome Measures

Name	Time	Method
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg)	5 days

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include evaluation of adverse events	5 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium