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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

NCT01080612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-29

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

330 mg pregabalin controlled release

A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal

DRUG

330 mg pregabalin controlled release

A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal

DRUG

330 mg pregabalin controlled release

A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal

DRUG

300 mg pregabalin immediate release

A single dose of 300 mg immediate release capsule will be administered in the fasted state

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
2010-04-30
Primary Completion
2010-06-30
Completion
2010-06-30

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 NCT01080612 on ClinicalTrials.gov