NCT02952937

Bioequivalence Study of Two Formulations of Pregabalin CR(Controlled-release) Table 300 mg

A Randomized, Open-label, Single Dose, Crossover Phase 1 Study to Compare the Pharmacokinetic Characteristics of GLA5PR GLARS-NF1 Tablet 300 mg and GLA5PR GLARS-NF3 Tablet 300 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GL Pharm Tech Corporation · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet and (2) determine the safety and tolerability of a single dose of GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg administered regular diet.

Detailed description

To assess the single dose pharmacokinetics, safety, and tolerability of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet. IP will be administered 1 tablet(300mg) once a day(QD) after evening meal.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLA5PR GLARS-NF3 tablet 300mg	A new formulation(3rd.) of Pregabalin CR tablet
DRUG	GLA5PR GLARS-NF1 tablet 300mg	A new formulation(1st.) of Pregabalin CR tablet

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-11-01
• Completion: 2017-04-01
• First posted: 2016-11-02
• Last updated: 2017-04-12

Locations

1 site across 1 country: South Korea