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Completed

NCT Number: NCT02103686

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19~44 aged healthy adult.
  • someone tho has at least 50kg body weight and ideal body weight ±20%

Exclusion criteria

  • someone has acute symptom at screening phase
  • someone has any disease or symptoms which is clinically significant
  • someone had been determined during healthy examination in screening period
  • AST or ALT > 1.25 times than normal
  • Total bilirubin > 1.5 times than normal
  • someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
  • someone who had enrolled to other clinical trial within the last 60 days.
  • someone who had donated blood within the last 60 days.
  • someone who can't take a meal derived from this trial.
  • someone who has taken abnormal meals like which can affect to drug ADME
  • someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
  • someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
  • someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
  • someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Treatment and study plan

lyrica

Drug

Experimental drug

Drug

sustained release formulation of pregabalin

High fat meal

Dietary Supplement

fasted

Dietary Supplement

Primary outcomes

  1. Cmax, AUC of pregabalin

    Time frame: 0~36h

Secondary outcomes

  1. Safety evaluation

    Time frame: 0~24day

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Official study title

A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 4, 2014
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.