Bioequivalence of Rebamipide in Korean

NCT00997789 | Completed DMC

• 1 other identifier: IBBS-BE-REBAMIPIDE-KYUNGDONG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapeutic Equivalency; Pharmacogenetics

Keywords

Rebamipide; Bioequivalence; ABCB1 genetic polymorphisms

Outcome Measures

Primary Outcomes (1)

• Serum concentration of rebamipide

  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 Outcomes (1)

• Genetic polymorphisms in ABCB1 gene (exon 21 and 26)

  A 3-mL blood sample was taken from each subject who participated in our bioequivalence studies before administration of rebamipide.

Study Arms (1)

Rebamipide, Serum concentration, Tablet

EXPERIMENTAL

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

Interventions

Rebamide DRUG

Rebamipide 100 mg Tablet, three times a day

Also known as: Mucosta® (Korea Otsuka Pharmaceuticals Co.)

Rebamipide, Serum concentration, Tablet

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU: collaborator

Study Sites (1)

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

Gwangju, 500-757, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20110013 DERIVED

Study Officials

• Yong-Bok Lee, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 19, 2009
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 19, 2009

Record last verified: 2009-10

Locations

KR (1)