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

NCT02952937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • GL Pharm Tech Corporation

    lead INDUSTRY

Principal Investigators

  • Min-Gul Kim, Ph.D. · Chonbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-11-30
Completion
2017-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02952937 on ClinicalTrials.gov