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An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

NCT01270815 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-01-22

No results posted yet for this study

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 a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

Conditions

  • Healthy

Interventions

DRUG

Pregabalin controlled release, 330 mg, 400 to 500 calories

A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch

DRUG

Pregabalin controlled release, 330 mg, 600 to 750 calories

A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch

DRUG

Pregabalin controlled release, 330 mg, 800 to 1000 calories

A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch

DRUG

Pregabalin immediate release, 300 mg

A single oral dose of 300 mg immediate release capsule administered fasted

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01270815 on ClinicalTrials.gov