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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd
• Treatments: Pregabalin

Criteria

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.