NCT Number: NCT02103686
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
The purpose of this study is to:
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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Notify MeKey information
Conditions
Age range
19 year–44 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 19~44 aged healthy adult.
- someone tho has at least 50kg body weight and ideal body weight ±20%
Exclusion criteria
- 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.
Treatment and study plan
Experimental drug
Drugsustained release formulation of pregabalin
High fat meal
Dietary Supplementfasted
Dietary SupplementPrimary outcomes
-
Cmax, AUC of pregabalin
Time frame: 0~36h
Secondary outcomes
-
Safety evaluation
Time frame: 0~24day
Sponsors and collaborators
Lead sponsor
IlDong Pharmaceutical Co Ltd
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2013
- First posted
- Apr 4, 2014
- Registry last updated
- Sep 1, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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