KCT0001476Completed未知
A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare 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
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Ildong pharmaceutical
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 45(Year) (—)
- Sex
- Male
Inclusion Criteria
- •Inclusion Criteria:
- •20~45 aged healthy adult.
- •someone tho has at least 50kg body weight and ideal body weight ±20%
Exclusion Criteria
- •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.
Investigators
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