S. Tippabhotla, S. Thota, Sohel Md. Khan, C. Gadiko, Sandeep Yergude, Raju Cheerla, Mukesh Nakkawar, Madhava Rao Betha, R. Battula, V. Vobalaboina
{"title":"阿仑膦酸钠/胆钙化醇(维生素D3)片70 mg/5600 IU两种剂型的药代动力学:开放标签、随机、单剂量、两治疗、两期、两顺序、交叉、生物等效性研究","authors":"S. Tippabhotla, S. Thota, Sohel Md. Khan, C. Gadiko, Sandeep Yergude, Raju Cheerla, Mukesh Nakkawar, Madhava Rao Betha, R. Battula, V. Vobalaboina","doi":"10.3109/10601333.2012.759586","DOIUrl":null,"url":null,"abstract":"Abstract A fixed dose combination of alendronate and cholecalciferol (vitamin D3) 70 mg/5600 IU tablets has been indicated for the treatment of osteoporosis. This study was aimed to assess bioequivalence between test and reference formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU in 110 healthy adult male volunteers under fasting conditions. This was an open label, randomized, single dose, two way cross-over study, separated by a washout period of 14 days. All possible efforts were made to stabilize the baseline endogenous levels of cholecalciferol. Blood samples were collected from 96 h pre-dose to 96 h post-dose and 0–24 h for cholecalciferol and alendronate, respectively. Quantification of alendronate and cholecalciferol was done using distinct validated LC-MS/MS methods. Two baseline adjusted methods, method-I (subtraction of the average concentration from each post-dose concentration) and method-II (subtraction of the individual AUC from post-dose AUC) were applied for deriving the AUC0–t parameter of cholecalciferol, among which bioequivalence was concluded based on data obtained using method-I. The 90% CI of Cmax and AUC0–t for alendronate and baseline adjusted cholecalciferol were within the regulatory acceptance limit of 80.00–125.00% and considered as bioequivalent.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2013-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Pharmacokinetics of two formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU: An open-label, randomized, single-dose, two-treatment, two-period, two-sequence, cross-over, bioequivalence study\",\"authors\":\"S. Tippabhotla, S. Thota, Sohel Md. Khan, C. Gadiko, Sandeep Yergude, Raju Cheerla, Mukesh Nakkawar, Madhava Rao Betha, R. Battula, V. Vobalaboina\",\"doi\":\"10.3109/10601333.2012.759586\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract A fixed dose combination of alendronate and cholecalciferol (vitamin D3) 70 mg/5600 IU tablets has been indicated for the treatment of osteoporosis. This study was aimed to assess bioequivalence between test and reference formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU in 110 healthy adult male volunteers under fasting conditions. This was an open label, randomized, single dose, two way cross-over study, separated by a washout period of 14 days. All possible efforts were made to stabilize the baseline endogenous levels of cholecalciferol. Blood samples were collected from 96 h pre-dose to 96 h post-dose and 0–24 h for cholecalciferol and alendronate, respectively. Quantification of alendronate and cholecalciferol was done using distinct validated LC-MS/MS methods. Two baseline adjusted methods, method-I (subtraction of the average concentration from each post-dose concentration) and method-II (subtraction of the individual AUC from post-dose AUC) were applied for deriving the AUC0–t parameter of cholecalciferol, among which bioequivalence was concluded based on data obtained using method-I. The 90% CI of Cmax and AUC0–t for alendronate and baseline adjusted cholecalciferol were within the regulatory acceptance limit of 80.00–125.00% and considered as bioequivalent.\",\"PeriodicalId\":10446,\"journal\":{\"name\":\"Clinical Research and Regulatory Affairs\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2013-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research and Regulatory Affairs\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3109/10601333.2012.759586\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2012.759586","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Pharmacokinetics of two formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU: An open-label, randomized, single-dose, two-treatment, two-period, two-sequence, cross-over, bioequivalence study
Abstract A fixed dose combination of alendronate and cholecalciferol (vitamin D3) 70 mg/5600 IU tablets has been indicated for the treatment of osteoporosis. This study was aimed to assess bioequivalence between test and reference formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU in 110 healthy adult male volunteers under fasting conditions. This was an open label, randomized, single dose, two way cross-over study, separated by a washout period of 14 days. All possible efforts were made to stabilize the baseline endogenous levels of cholecalciferol. Blood samples were collected from 96 h pre-dose to 96 h post-dose and 0–24 h for cholecalciferol and alendronate, respectively. Quantification of alendronate and cholecalciferol was done using distinct validated LC-MS/MS methods. Two baseline adjusted methods, method-I (subtraction of the average concentration from each post-dose concentration) and method-II (subtraction of the individual AUC from post-dose AUC) were applied for deriving the AUC0–t parameter of cholecalciferol, among which bioequivalence was concluded based on data obtained using method-I. The 90% CI of Cmax and AUC0–t for alendronate and baseline adjusted cholecalciferol were within the regulatory acceptance limit of 80.00–125.00% and considered as bioequivalent.