Bioequivalence of Rebamipide in Korean

This study has been completed.
Sponsor:
Collaborator:
Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
Information provided by:
Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT00997789
First received: October 14, 2009
Last updated: October 18, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Therapeutic Equivalency
Pharmacogenetics
Drug: Rebamide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Evaluation of Two Rebamipide Preparations After a Single Oral Dose to Healthy Korean Volunteers

Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Serum concentration of rebamipide [ Time Frame: Pre-dose (to serve as a control) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 12 hours after oral administration of rebamipide tablet (100 mg) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Genetic polymorphisms in ABCB1 gene (exon 21 and 26) [ Time Frame: A 3-mL blood sample was taken from each subject who participated in our bioequivalence studies before administration of rebamipide. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rebamipide, Serum concentration, Tablet
The test preparation, Rebamide® (containing 100 mg of rebamipide; lot No. KP005; expiration date, April 2010; Kyungdong Pharmaceutical Company, Seoul, Korea) and the reference preparation, Mucosta® (containing 100 mg of rebamipide; lot No. MC704067; expiration date, May 2010; Korea Otsuka Pharmaceuticals Co., Ltd., Seoul, Korea)
Drug: Rebamide
Rebamipide 100 mg Tablet, three times a day
Other Name: Mucosta® (Korea Otsuka Pharmaceuticals Co.)

Detailed Description:

A randomized, single-dose, 2-period crossover design with a 7-day washout period was conducted in 30 healthy Korean male volunteers. Subjects were randomly assigned to receive a single 100-mg dose of the test or reference preparation of rebamipide, administered with 240 mL of water after a 12-hour overnight fast. All subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests. Serum concentrations of rebamipide up to 12 hours after administration were determined using a validated HPLC method with fluorescence detection. Adverse events (AEs) were continuously monitored by clinical staff via observation, personal interview, and vital signs (temperature, blood pressure, heart rate) during the study period. All adverse events were recorded on the clinical record form per subject up to 1 week after the study. Pharmacokinetic parameters were determined using a noncompartmental method. The preparations were considered bioequivalent if the log-transformed ratios of AUC0-t, AUC0-∞, and Cmax were within the predetermined bioequivalence range (ie, 80-125%), as set by the US Food and Drug Administration (FDA) and Korean legislation. In vitro dissolution profiles of both preparations were examined and the influence of genetic polymorphisms in ABCB1 gene (P-glycoprotein) on the pharmacokinetics of rebamipide was also investigated.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests (blood analysis; hemoglobin, hematocrit, RBC, WBC, platelet, differential counting of WBC, total proteins, albumin, ALT, AST, alkaline phosphatase, total bilirubin, cholesterol, creatinine, blood urea nitrogen, and fasting glucose and urine analysis; specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and cast).

Exclusion Criteria:

  • Subjects possibly sensitive to this type of preparation,
  • Subjects who had a history of any hepatic illness,
  • Subjects who had a history of any renal illness,
  • Subjects who had a history of any respiratory illness,
  • Subjects who had a history of any endocrine illness,
  • Subjects who had a history of any cardiovascular system illness,
  • Subjects who had taken alcohol within 4 weeks prior to the study,
  • Subjects who had taken other preparations within 4 weeks prior to the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00997789

Locations
Korea, Republic of
Institute of Bioeqivalence and Bridging Study, College of Pharmacy, CNU
Gwangju, Korea, Republic of, 500-757
Sponsors and Collaborators
Chonnam National University Hospital
Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
Investigators
Principal Investigator: Yong-Bok Lee, Ph.D. Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
  More Information

No publications provided by Chonnam National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yong-Bok Lee, Professor and Director, Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
ClinicalTrials.gov Identifier: NCT00997789     History of Changes
Other Study ID Numbers: IBBS-BE-REBAMIPIDE-KYUNGDONG
Study First Received: October 14, 2009
Last Updated: October 18, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonnam National University Hospital:
Rebamipide
Bioequivalence
ABCB1 genetic polymorphisms

Additional relevant MeSH terms:
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014