Bioequivalence of Rebamipide in Korean
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ClinicalTrials.gov Identifier: NCT00997789 |
Recruitment Status
:
Completed
First Posted
: October 19, 2009
Last Update Posted
: October 19, 2009
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Condition or disease | Intervention/treatment | Phase |
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Therapeutic Equivalency Pharmacogenetics | Drug: Rebamide | Not Applicable |
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 |
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)
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Drug: Rebamide
Rebamipide 100 mg Tablet, three times a day
Other Name: Mucosta® (Korea Otsuka Pharmaceuticals Co.)
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- 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) ]
- 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. ]

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Ages Eligible for Study: | 19 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997789
Korea, Republic of | |
Institute of Bioeqivalence and Bridging Study, College of Pharmacy, CNU | |
Gwangju, Korea, Republic of, 500-757 |
Principal Investigator: | Yong-Bok Lee, Ph.D. | Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU |
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 |
First Posted: | October 19, 2009 Key Record Dates |
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 |