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

August 28, 2014 updated by: IlDong Pharmaceutical Co Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate release capsule
Immediate release capsule treatment under fasted condition
Drug: Lyrica
Dietary supplement: fasted
Experimental: sustained release tablet
sustained release tablet treatment under fasted condition
Dietary supplement: fasted
Drug: Experimental drug
sustained release formulation of pregabalin
Experimental: sustained release tablet (high fat meal)
sustained release tablet under high fat meal condition.
Dietary supplement: High fat meal
Drug: Experimental drug
sustained release formulation of pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax, AUC of pregabalin
Time Frame: 0~36h
0~36h

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety evaluation
Time Frame: 0~24day
0~24day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IlDong Pharmaceutical Co Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-PRSD-1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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