NCT02103686CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 30
- Primary Endpoint
- Cmax, AUC of pregabalin
Study Overview
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).
- Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 44 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Immediate release capsule
Active Comparator
Immediate release capsule treatment under fasted condition
Intervention: Lyrica (Drug)
Immediate release capsule
Active Comparator
Immediate release capsule treatment under fasted condition
Intervention: fasted (Dietary Supplement)
sustained release tablet
Experimental
sustained release tablet treatment under fasted condition
Intervention: Experimental drug (Drug)
sustained release tablet
Experimental
sustained release tablet treatment under fasted condition
Intervention: fasted (Dietary Supplement)
sustained release tablet (high fat meal)
Experimental
sustained release tablet under high fat meal condition.
Intervention: Experimental drug (Drug)
sustained release tablet (high fat meal)
Experimental
sustained release tablet under high fat meal condition.
Intervention: High fat meal (Dietary Supplement)
Outcomes
Primary Outcomes
Cmax, AUC of pregabalin
Time Frame: 0~36h
Secondary Outcomes
- Safety evaluation(0~24day)
Investigators
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