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Comparison of the bioavailability and tolerability of fixed-dose combination glimepiride/metformin 2/500-mg tablets versus separate tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Korean volunteers
DC Field | Value | Language |
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dc.contributor.author | 정재용 | - |
dc.date.accessioned | 2015-04-23T17:02:46Z | - |
dc.date.available | 2015-04-23T17:02:46Z | - |
dc.date.issued | 2010 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/101720 | - |
dc.description.abstract | OBJECTIVE: This study compared the bioavailability and tolerability of a fixed-dose combination (FDC) tablet of glimepiride/metformin 2/500 mg and glimepiride 2-mg + metformin 500-mg tablets administered separately in healthy Korean subjects. METHODS: In this single-dose, open-label, 2-period crossover study, healthy Korean volunteers were randomly assigned to receive, in 1 of 2 randomized sequences, an FDC tablet of glimepiride/metformin 2/500 mg (test) and glimepiride 2-mg + metformin 500-mg tablets administered separately (reference), with a 1-week washout period between treatments. Plasma concentrations of glimepiride and metformin were measured using LC/MS-MS. Pharmacokinetic parameters were analyzed using noncompartmental methods. Bioequivalence was concluded if the 90% CIs of the geometric mean test/reference ratios (GMRs) of the logarithm-transformed C(max), AUC from 0 to 30 hours (AUC(0-30)), and AUC(0-infinity) values were within the predetermined regulatory range of 80% to 125%. Tolerability was assessed using physical examination and laboratory analysis. RESULTS: A total of 32 subjects were enrolled (16 men [mean (SD) age, 21.8 (2.7) years (range, 18-26 years); weight, 68.9 (8.3) kg (range, 55.5-85.0 kg)]; 16 women [age, 23.5 (4.5) years (range, 20-38 years); weight, 51.7 (3.5) kg (range, 46.8-58.0 kg)]). The GMRs (90% CI) of glimepiride C(max), AUC(0-30), and AUC(0-infinity) were 1.01 (0.91-1.11), 0.98 (0.92-1.03), and 0.97 (0.93-1.04), respectively. For metformin, these values were 0.96 (0.87-1.06), 0.96 (0.90-1.03), and 0.96 (0.90-1.03). A total of 49 adverse events (AEs) were reported in 10 subjects (31.3%) with the FDC and in 13 subjects (40.6%) with the separate tablets. The most commonly reported AEs with the test and reference treatments were dizziness (6 [19%] and 7 [22%]) and sweating (4 [13%] and 7 [22%]), respectively. The severity of all of the AEs was considered to be mild, and there were no significant differences in the prevalences of AEs between the 2 formulations. CONCLUSIONS: In this study in healthy Korean subjects, the requirements for bioequivalence of the glimepiride/metformin 2/500-mg FDC and coadministration of separate tablets of each drug were met. Both formulations were generally well tolerated. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 1408~1418 | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adolescent | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Area Under Curve | - |
dc.subject.MESH | Asian Continental Ancestry Group | - |
dc.subject.MESH | Chromatography, Liquid/methods | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Drug Combinations | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hypoglycemic Agents/administration & dosage | - |
dc.subject.MESH | Hypoglycemic Agents/adverse effects | - |
dc.subject.MESH | Hypoglycemic Agents/pharmacokinetics* | - |
dc.subject.MESH | Korea | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Metformin/administration & dosage | - |
dc.subject.MESH | Metformin/adverse effects | - |
dc.subject.MESH | Metformin/pharmacokinetics* | - |
dc.subject.MESH | Sulfonylurea Compounds/administration & dosage | - |
dc.subject.MESH | Sulfonylurea Compounds/adverse effects | - |
dc.subject.MESH | Sulfonylurea Compounds/pharmacokinetics* | - |
dc.subject.MESH | Tablets | - |
dc.subject.MESH | Tandem Mass Spectrometry/methods | - |
dc.subject.MESH | Therapeutic Equivalency | - |
dc.subject.MESH | Young Adult | - |
dc.title | Comparison of the bioavailability and tolerability of fixed-dose combination glimepiride/metformin 2/500-mg tablets versus separate tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Korean volunteers | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pharmacology (약리학) | - |
dc.contributor.googleauthor | Seung Eun Jung | - |
dc.contributor.googleauthor | Yong Kwan Kim | - |
dc.contributor.googleauthor | Dong-Ye Youn | - |
dc.contributor.googleauthor | Mi-Hyun Lim | - |
dc.contributor.googleauthor | Jeong Heon Ko | - |
dc.contributor.googleauthor | Young Soo Ahn | - |
dc.contributor.googleauthor | Jeong-Hwa Lee | - |
dc.identifier.doi | 10.1016/j.clinthera.2010.07.012 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A03709 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 20678687 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0149291810002390 | - |
dc.subject.keyword | glimepiride | - |
dc.subject.keyword | metformin | - |
dc.subject.keyword | combination | - |
dc.subject.keyword | pharmacokinetics | - |
dc.subject.keyword | healthy subjects | - |
dc.contributor.alternativeName | Chung, Jae Yong | - |
dc.contributor.affiliatedAuthor | Chung, Jae Yong | - |
dc.citation.volume | 32 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 1408 | - |
dc.citation.endPage | 1418 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.32(7) : 1408-1418, 2010 | - |
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