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
NCT ID: NCT02103686
Last Updated: 2014-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2012-11-30
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Immediate release capsule
Immediate release capsule treatment under fasted condition
Lyrica
fasted
sustained release tablet
sustained release tablet treatment under fasted condition
Experimental drug
sustained release formulation of pregabalin
fasted
sustained release tablet (high fat meal)
sustained release tablet under high fat meal condition.
Experimental drug
sustained release formulation of pregabalin
High fat meal
Interventions
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Lyrica
Experimental drug
sustained release formulation of pregabalin
High fat meal
fasted
Eligibility Criteria
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Inclusion Criteria
* someone tho has at least 50kg body weight and ideal body weight ±20%
Exclusion Criteria
* 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.
19 Years
44 Years
MALE
Yes
Sponsors
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IlDong Pharmaceutical Co Ltd
INDUSTRY
Responsible Party
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Other Identifiers
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ID-PRSD-1201
Identifier Type: -
Identifier Source: org_study_id
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