Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation

IlDong Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: sustained release tablet

Drug: Immediate release capsule(lyrica 150mg * 2/day)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02103647

ID-PRMD-1202

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg * 2) while multiple dosing.

Enrollment

24 patients

Sex

Male

Ages

19 to 44 years old

Volunteers

Accepts Healthy Volunteers

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.