Bioequivalence of Rebamipide in Korean

NCT ID: NCT00997789

Last Updated: 2009-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Therapeutic Equivalency; Pharmacogenetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Rebamide

Intervention Type: DRUG

Rebamipide 100 mg Tablet, three times a day

Interventions

Rebamide

Rebamipide 100 mg Tablet, three times a day

Intervention Type: DRUG

Other Intervention Names

Mucosta® (Korea Otsuka Pharmaceuticals Co.)

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Yong-Bok Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Institute of Bioeqivalence and Bridging Study, College of Pharmacy, CNU

Gwangju, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 20110013 (View on PubMed)

Other Identifiers

IBBS-BE-REBAMIPIDE-KYUNGDONG

Identifier Type: -

Identifier Source: org_study_id