Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulatio
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0001431
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 24
20~45 aged healthy adult.
someone tho has at least 50kg body weight and ideal body weight ±20%
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 > 1.5 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 Absorbtion, Distribution, Metabolism, Excretion
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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure blood concentration of pregabalin
- Secondary Outcome Measures
Name Time Method safety evaluation