Status:
COMPLETED
Bioequivalence of Rebamipide in Korean
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
Conditions:
Therapeutic Equivalency
Pharmacogenetics
Eligibility:
MALE
19-50 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00997789
Start Date
March 1 2008
End Date
December 1 2008
Last Update
October 19 2009
Active Locations (1)
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1
Institute of Bioeqivalence and Bridging Study, College of Pharmacy, CNU
Gwangju, South Korea, 500-757