Bioequivalence of Rebamipide in Korean
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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 |
- 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 ]
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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 Antioxidants Enzyme Inhibitors Gastrointestinal Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015