An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pregabalin controlled release, 330 mg, low-fat; Drug: Pregabalin controlled release, 330 mg, medium-fat; Drug: Pregabalin immediate release, 300 mg; Drug: Pregabalin controlled release, 330 mg, high-fat

• Registration Number: NCT01257529
• 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 a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.

Detailed Description

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Study Timeline

• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2011-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2018-09
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 controlled release, 330 mg, low-fat	Pregabalin controlled release, 330 mg, low-fat	-
Pregabalin controlled release, 330 mg, medium-fat	Pregabalin controlled release, 330 mg, medium-fat	-
Pregabalin immediate release, 300 mg	Pregabalin immediate release, 300 mg	Reference Treatment
Pregabalin controlled release, 330 mg, high-fat	Pregabalin controlled release, 330 mg, high-fat	-

Primary Outcome Measures

Name	Time	Method
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments	3 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States