Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00997789
Status:
COMPLETED
Last Update Posted:
2009-10-19
First Post:
2009-10-14
Brief Title:
Bioequivalence of Rebamipide in Korean
Sponsor:
Chonnam National University Hospital
Organization:
Chonnam National University Hospital
Study Overview
Official Title:
Bioequivalence Evaluation of Two Rebamipide Preparations After a Single Oral Dose to Healthy Korean Volunteers
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None