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

Phase 1

Completed

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

• Registration Number: NCT01080612
• 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 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.

Study Timeline

• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-04
• Study Start: 2010-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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
330 mg pregabalin controlled release: 400 to 500 calories	330 mg pregabalin controlled release	-
330 mg pregabalin controlled release: 600 to 750 calories	330 mg pregabalin controlled release	-
330 mg pregabalin controlled release: 800 to 1000 calories	330 mg pregabalin controlled release	-
300 mg pregabalin immediate release	300 mg pregabalin immediate release	-

Primary Outcome Measures

Name	Time	Method
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)	3 days

Secondary Outcome Measures

Name	Time	Method
Adverse events, vital signs, and clinical safety laboratories.	3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States