Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation
A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2) while multiple dosing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started May 2013
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedSeptember 1, 2014
April 1, 2013
1 month
March 18, 2014
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure blood concentration of pregabalin
0~4day / 14~18day
Secondary Outcomes (1)
Safety evaluation
0~25day
Study Arms (2)
Immediate release capsule(lyrica capsule 150mg)
ACTIVE COMPARATORImmediate release capsule repeat treatment for 3days under fasted condition
sustained release tablet
EXPERIMENTALsustained release tablet repeat treatment for 3days under fasted condition
Interventions
Immediate release capsule
Eligibility Criteria
You may qualify if:
- \~44 aged healthy adult.
- someone tho has at least 50kg body weight and ideal body weight ±20%
You may not qualify if:
- 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 \> 1.25 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic medical center
Seoul, Seocho-gu, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
April 4, 2014
Study Start
May 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 1, 2014
Record last verified: 2013-04