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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Experimental drug; Drug: Lyrica; Dietary Supplement: fasted; Dietary Supplement: High fat meal

• Registration Number: NCT02103686
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-11
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sustained release tablet	fasted	sustained release tablet treatment under fasted condition
Immediate release capsule	fasted	Immediate release capsule treatment under fasted condition
sustained release tablet (high fat meal)	Experimental drug	sustained release tablet under high fat meal condition.
Immediate release capsule	Lyrica	Immediate release capsule treatment under fasted condition
sustained release tablet	Experimental drug	sustained release tablet treatment under fasted condition
sustained release tablet (high fat meal)	High fat meal	sustained release tablet under high fat meal condition.

Primary Outcome Measures

Name	Time	Method
Cmax, AUC of pregabalin	0~36h

Secondary Outcome Measures

Name	Time	Method
Safety evaluation	0~24day