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Bioequivalence of Rebamipide in Korean

NCT00997789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-10-19

No results posted yet for this study

Summary

The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of two rebamipide preparations in healthy Korean male volunteers for generic substitution and to evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and rebamipide disposition.

Conditions

  • Therapeutic Equivalency
  • Pharmacogenetics

Interventions

DRUG

Rebamide

Rebamipide 100 mg Tablet, three times a day

Sponsors & Collaborators

  • Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU

    collaborator UNKNOWN

  • Chonnam National University Hospital

    lead OTHER

Principal Investigators

  • Yong-Bok Lee, Ph.D. · Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-04-30
Completion
2008-12-31

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 NCT00997789 on ClinicalTrials.gov