Bioavailability and Bioequivalence of Two Oral Formulations of Alendronate Sodium 70 mg: An Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Korean Adult Male Volunteers
DC Field | Value | Language |
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dc.contributor.author | Rhim, Si-Youn | - |
dc.contributor.author | Park, Jin-Hee | - |
dc.contributor.author | Park, Yoo-Sin | - |
dc.contributor.author | Lee, Min-Ho | - |
dc.contributor.author | Kim, Dong-Sun | - |
dc.contributor.author | Shaw, Leslie M. | - |
dc.contributor.author | Yang, Seok-Chul | - |
dc.contributor.author | Kang, Ju-Seop | - |
dc.date.accessioned | 2022-12-20T22:25:56Z | - |
dc.date.available | 2022-12-20T22:25:56Z | - |
dc.date.created | 2022-08-26 | - |
dc.date.issued | 2009-05 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/176863 | - |
dc.description.abstract | Background: Alendronate sodium is a bisphosphonate drug used to treat and prevent osteoporosis and several other bone diseases. A new formulation has been developed and is currently awaiting regulatory approval, pending findings on bioequivalence. Objectives: The alms of the present study were to compare the bioavailability and pharmacokinetic (PK) properties, and to determine the bioequivalence, of a test and reference formulation of alendronate sodium 70 mg in a healthy Korean adult male population. Methods: This open-label, randomized, 2-sequence, 2-period crossover study was carried out at Hanyang University Medical Center (Seoul, Republic of Korea). Healthy Korean adult male volunteers were randomly assigned to receive a single 70-mg dose of the test or reference formulation of alendronate sodium, administered with 240 mL of water, followed by a 7-day washout period and administration of the alternate formulation. The study drugs were administered after a 12-hour overnight fast. Serial blood samples were collected and adverse events were monitored by a clinical investigator via observation, personal intern view, and vital signs (blood pressure, heart rate, and body temperature) over a 7-hour period (at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, and 7 hours) after drug administration. Plasma alendronate sodium concentrations were determined using a validated high-performance liquid chromatographic-postcolumn fluorescence derivatization method, with visible detection in the range of 2 to 100 ng/mL and lower limit of quantification set at 2 ng/mL. PK properties, including AUC(0-t), AUC(0-infinity), C-max T-max, t(1/2), and the elimination constant (k(e)), were determined using noncompartmental analysis. The formulations were considered bloequivalent if the 90% CI ratios for C-max and AUC were within the predetermined interval of 80% to 125%, the regulatory definition set by the US Food and Drug Administration (FDA). Results: Twenty-three healthy male volunteers (mean [SD] age, 23.5 [2.0] years [range, 19-28 years]; height, 175.9 [5.4] cm [range, 162.0-185.0 cm]; and weight, 71.2 [9.5] kg [range, 61-96 kg]) were included in the study. No period or sequence effects were detected. The 90% CIs for the corresponding ratios of AUC(0-t), AUC(0-infinity), and C-max were 84.97 to 114.47, 86.09 to 115.59, and 82.37 to 110.71, respectively. Additionally, the mean (range) of T-max was 1.09 hours (0.5-2.0 hours), and the mean (SD) of t(1/2) and k(e) were 2.04 (0.97) hours and 0.34 (0.71.) hour, respectively. The values for the test and reference formulations were within the FDA bioequivalence definition interval of 80% to 125%. No adverse events were reported in this study. Conclusions: Single doses of these formulations of alendronate sodium 70 mg met the criteria for bioequivalence. No statistically significant differences in AUC(0-t), AUC(0-infinity), and C-max were found in this healthy Korean adult male population. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER | - |
dc.title | Bioavailability and Bioequivalence of Two Oral Formulations of Alendronate Sodium 70 mg: An Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Korean Adult Male Volunteers | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Sun | - |
dc.contributor.affiliatedAuthor | Kang, Ju-Seop | - |
dc.identifier.doi | 10.1016/j.clinthera.2009.05.001 | - |
dc.identifier.scopusid | 2-s2.0-66949179352 | - |
dc.identifier.wosid | 000267248000009 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, v.31, no.5, pp.1037 - 1045 | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.citation.title | CLINICAL THERAPEUTICS | - |
dc.citation.volume | 31 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1037 | - |
dc.citation.endPage | 1045 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | MASS-SPECTROMETRY | - |
dc.subject.keywordPlus | HUMAN URINE | - |
dc.subject.keywordPlus | BISPHOSPHONATES | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.subject.keywordPlus | FLUORESCENCE | - |
dc.subject.keywordAuthor | alendronate sodium | - |
dc.subject.keywordAuthor | bioequivalence test | - |
dc.subject.keywordAuthor | pharmacokinetics | - |
dc.subject.keywordAuthor | HPLC-FLD method | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S0149291809001477?via%3Dihub | - |
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