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
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0001476
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria:
20~45 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 as 'not suitable for study' during healthy examination(medical history, physical exam, lab test, Etc) in screening period
someone had some lab data below.
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 or who donated substance of blood with in last 20 days.
someone who can't take a meal derived from this trial.
someone who has taken abnormal meals like which can affect to drug Absorbtion, Distribution, Metabolism, Excretion.
someone who can't stop taking grapefuit contained foods.
someone who has taken other prescription medicine or oriental drugs within the last 14 days, Or Over the counter drugs within the last 7 days
someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or who can't stop the caffein since 24hours before hospitalization.
someone who has taken alcohol more than 30g/day or someone who can't stop drinking from 24hours before enrollment to discharging from hospital.
someone who smoked more than 10 piece of tobacco/day or can't stop smoking from 24hours before enrollment to discharging from hospital.
someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure blood concentration of pregabalin
- Secondary Outcome Measures
Name Time Method safety evaluation