Linked Life Data

19998583

Source:http://linkedlifedata.com/resource/pubmed/id/19998583

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
10
pubmed:dateCreated
2009-12-10
pubmed:abstractText
The study was designed to compare the rate and extent of absorption of a fixed dose combination tablet of lamivudine (CAS 134678-17-4) and stavudine (CAS 3056-17-5) with the concurrent administration of lamivudine tablet and stavudine capsule in 24 healthy volunteers under fasting conditions. The volunteers were randomly assigned to the test or reference treatment, with the two treatment periods separated by a washout period of at least 7 days. Plasma samples were analyzed for both analytes lamivudine and stavudine by a validated analytical method. Since the 90% confidence intervals for the "test/reference" mean ratio of the In-transformed pharmacokinetic variables C(max) AUC(0-t) and AUC(0-infinity) were clearly within the conventional bioequivalence range of 80% to 125%, the two treatments were considered bioequivalent. The safety profiles of both the test and reference formulations were comparable.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0004-4172
pubmed:author
pubmed:issnType
Print
pubmed:volume
59
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
537-40
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
Bioequivalence evaluation of a fixed dose combination lamivudine + stavudine tablet with concurrent administration of lamivudine tablet and stavudine capsule in healthy volunteers.
pubmed:affiliation
Department of Clinical and Bioequivalence Research, Cipla Limited, Mumbai, India.
pubmed:publicationType
Journal Article, Randomized Controlled Trial