Bioequivalence of Rebamipide in Korean

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Therapeutic Equivalency; Pharmacogenetics	Drug: Rebamide	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Bioequivalence Evaluation of Two Rebamipide Preparations After a Single Oral Dose to Healthy Korean Volunteers
Study Start Date :	March 2008
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	December 2008

Arms and Interventions

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Arm	Intervention/treatment
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.)

Outcome Measures

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Primary Outcome Measures :

1. 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) ]

Secondary Outcome Measures :

1. 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. ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 50 Years (Adult)
Sexes 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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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cho HY, Yoon H, Park GK, Lee YB. Pharmacokinetics and bioequivalence of two formulations of rebamipide 100-mg tablets: a randomized, single-dose, two-period, two-sequence crossover study in healthy Korean male volunteers. Clin Ther. 2009 Nov;31(11):2712-21. doi: 10.1016/j.clinthera.2009.11.010.

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
First Posted:	October 19, 2009
Last Update Posted:	October 19, 2009
Last Verified:	October 2009

Keywords provided by Chonnam National University Hospital:

Rebamipide; Bioequivalence; ABCB1 genetic polymorphisms

Additional relevant MeSH terms:

Rebamipide; Anti-Ulcer Agents; Gastrointestinal Agents; Antioxidants	Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Enzyme Inhibitors