pubmed-article:19537528 | rdf:type | pubmed:Citation | lld:pubmed |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C1708335 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0231441 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0178602 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0443218 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C2827483 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0039225 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0039789 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0939237 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C2603343 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0524527 | lld:lifeskim |
pubmed-article:19537528 | lifeskim:mentions | umls-concept:C0205195 | lld:lifeskim |
pubmed-article:19537528 | pubmed:issue | 5 | lld:pubmed |
pubmed-article:19537528 | pubmed:dateCreated | 2009-6-22 | lld:pubmed |
pubmed-article:19537528 | pubmed:abstractText | The study was designed to compare the rate and extent of absorption of two fixed dose combination tablet formulations of lopinavir (CAS 192725-17-0) and ritonavir (CAS 155213-67-5). This bioequivalence study was conducted using a standard preparation as reference and a generic alternative as test in 72 adult healthy volunteers within 18-45 years of age who received a single dose of the test or reference product under fasting conditions. A washout period of 10 d was maintained between period I and period II dosing. After dosing, blood samples were collected from 0 h (pre-dose) to 72 h postdose administration. Lopinavir and ritonavir were quantified using a validated LC-MS/MS method. The data obtained for each subject was evaluated for primary pharmacokinetic variables C(max), AUC(0-72), and AUC(0-Inf) with respect to % ratio and 90% confidence interval for log-transformed data. The 90% confidence intervals (obtained by analysis of variance, ANOVA) were well within the bioequivalence acceptance range of 80% to 125%. Thus, it can be concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption. The safety profiles of both the test and reference formulations were comparable. | lld:pubmed |
pubmed-article:19537528 | pubmed:language | eng | lld:pubmed |
pubmed-article:19537528 | pubmed:journal | http://linkedlifedata.com/r... | lld:pubmed |
pubmed-article:19537528 | pubmed:citationSubset | IM | lld:pubmed |
pubmed-article:19537528 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
pubmed-article:19537528 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
pubmed-article:19537528 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
pubmed-article:19537528 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
pubmed-article:19537528 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
pubmed-article:19537528 | pubmed:status | MEDLINE | lld:pubmed |
pubmed-article:19537528 | pubmed:issn | 0004-4172 | lld:pubmed |
pubmed-article:19537528 | pubmed:author | pubmed-author:LullaAmarA | lld:pubmed |
pubmed-article:19537528 | pubmed:author | pubmed-author:MalhotraGeena... | lld:pubmed |
pubmed-article:19537528 | pubmed:author | pubmed-author:PurandareShri... | lld:pubmed |
pubmed-article:19537528 | pubmed:author | pubmed-author:ChachadSiddar... | lld:pubmed |
pubmed-article:19537528 | pubmed:issnType | Print | lld:pubmed |
pubmed-article:19537528 | pubmed:volume | 59 | lld:pubmed |
pubmed-article:19537528 | pubmed:owner | NLM | lld:pubmed |
pubmed-article:19537528 | pubmed:authorsComplete | Y | lld:pubmed |
pubmed-article:19537528 | pubmed:pagination | 263-8 | lld:pubmed |
pubmed-article:19537528 | pubmed:dateRevised | 2011-11-17 | lld:pubmed |
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pubmed-article:19537528 | pubmed:year | 2009 | lld:pubmed |
pubmed-article:19537528 | pubmed:articleTitle | Bioequivalence study of two fixed dose combination tablet formulations of lopinavir and ritonavir in healthy volunteers. | lld:pubmed |
pubmed-article:19537528 | pubmed:affiliation | Department of Clinical and Bioequivalence Research, Cipla Ltd., Mumbai, India. siddharth.chachad@cipla.com | lld:pubmed |
pubmed-article:19537528 | pubmed:publicationType | Journal Article | lld:pubmed |
pubmed-article:19537528 | pubmed:publicationType | Randomized Controlled Trial | lld:pubmed |