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

NCT02103686 | Completed Phase 1

• 1 other identifier: ID-PRSD-1201
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to:

1. 1.Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2).
2. 2.Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.

Conditions

Healthy

Keywords

Neuropathic pain; pregabalin

Outcome Measures

Primary Outcomes (1)

• Cmax, AUC of pregabalin

  0~36h

Secondary Outcomes (1)

• Safety evaluation

  0~24day

Study Arms (3)

Immediate release capsule

ACTIVE COMPARATOR

Immediate release capsule treatment under fasted condition

Drug: Lyrica; Dietary Supplement: fasted

sustained release tablet

EXPERIMENTAL

sustained release tablet treatment under fasted condition

Drug: Experimental drug; Dietary Supplement: fasted

sustained release tablet (high fat meal)

EXPERIMENTAL

sustained release tablet under high fat meal condition.

Drug: Experimental drug; Dietary Supplement: High fat meal

Interventions

Lyrica DRUG

Immediate release capsule

Experimental drug DRUG

sustained release formulation of pregabalin

sustained release tablet; sustained release tablet (high fat meal)

High fat meal DIETARY_SUPPLEMENT

sustained release tablet (high fat meal)

fasted DIETARY_SUPPLEMENT

Immediate release capsule; sustained release tablet

Eligibility Criteria

• Age: 19 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin; Drugs, Investigational

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

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: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: September 1, 2014

Record last verified: 2012-09