Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation
NCT ID: NCT02103647
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
24 participants
INTERVENTIONAL
2013-05-31
2013-06-30
Brief Summary
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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(lyrica capsule 150mg)
Immediate release capsule repeat treatment for 3days under fasted condition
Immediate release capsule(lyrica 150mg * 2/day)
Immediate release capsule
sustained release tablet
sustained release tablet repeat treatment for 3days under fasted condition
sustained release tablet
sustained release tablet
Interventions
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Immediate release capsule(lyrica 150mg * 2/day)
Immediate release capsule
sustained release tablet
sustained release tablet
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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Locations
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Catholic medical center
Seoul, Seocho-gu, South Korea
Countries
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Other Identifiers
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ID-PRMD-1202
Identifier Type: -
Identifier Source: org_study_id
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