Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation

A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103647

Enrollment

Registered

2014-04-04

Start date

2013-05-31

Completion date

2013-06-30

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 compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2) while multiple dosing.

Interventions

DRUGImmediate release capsule(lyrica 150mg * 2/day)

Immediate release capsule

DRUGsustained release tablet

sustained release tablet

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
Measure blood concentration of pregabalin	0~4day / 14~18day

Secondary

Measure	Time frame
Safety evaluation	0~25day

Countries

South Korea

Outcome results

None listed

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