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Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects

NCT02103686 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-09-01

No results posted yet for this study

Summary

The purpose of this study is to:

1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2).
2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.

Conditions

  • Healthy

Interventions

DRUG

Lyrica

DRUG

Experimental drug

sustained release formulation of pregabalin

DIETARY_SUPPLEMENT

High fat meal

DIETARY_SUPPLEMENT

fasted

Sponsors & Collaborators

  • IlDong Pharmaceutical Co Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-12-31
Completion
2013-01-31

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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 NCT02103686 on ClinicalTrials.gov