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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103686

Enrollment

Registered

2014-04-04

Start date

2012-11-30

Completion date

2013-01-31

Last updated

2014-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Neuropathic pain, pregabalin

Brief summary

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.

Interventions

DRUGLyrica

DRUGExperimental drug

sustained release formulation of pregabalin

DIETARY_SUPPLEMENTHigh fat meal

DIETARY_SUPPLEMENTfasted

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 44 Years

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.

Design outcomes

Primary

Measure	Time frame
Cmax, AUC of pregabalin	0~36h

Secondary

Measure	Time frame
Safety evaluation	0~24day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026