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

IlDong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: fasted; Drug: Lyrica; Drug: Experimental drug; Dietary Supplement: High fat meal

Study type: Interventional

Funder types: Industry

Identifiers

NCT02103686

ID-PRSD-1201

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 19 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Immediate release capsule

Active Comparator group

Description:

Immediate release capsule treatment under fasted condition

Treatment:

Dietary Supplement: fasted

Drug: Lyrica

sustained release tablet

Experimental group

Description:

sustained release tablet treatment under fasted condition

Treatment:

Dietary Supplement: fasted

Drug: Experimental drug

sustained release tablet (high fat meal)

Experimental group

Description:

sustained release tablet under high fat meal condition.

Treatment:

Dietary Supplement: High fat meal

Drug: Experimental drug