Switch to
Predicate | Object |
---|---|
rdf:type | |
lifeskim:mentions | |
pubmed:issue |
4A
|
pubmed:dateCreated |
1997-8-13
|
pubmed:abstractText |
The tolerability and safety of ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]ethyl]amino]methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) and its basic pharmacokinetic parameters were determined after its oral administration to healthy volunteers. Sixteen subjects were selected to participate in two different studies: an increasing single dose study to determine the maximal tolerated dose (from 25 to 1600 mg), and a multiple dose study (stepped doses from 400 to 1600 mg daily for 12 days). The results of the studies showed that ebrotidine has a good tolerability. Vital signs and laboratory tests were not influenced by the study treatment. No clinically relevant adverse effects were reported during the investigation. Ebrotidine reached peak plasma concentrations 2-3 h after oral administration. Its elimination half-life ranged from 9 to 14 h. In conclusion, ebrotidine was well tolerated after administration of oral single doses of up to 1600 mg, and after repeated administration of up to 800 mg/12 h for 12 days.
|
pubmed:language |
eng
|
pubmed:journal | |
pubmed:citationSubset |
IM
|
pubmed:chemical | |
pubmed:status |
MEDLINE
|
pubmed:month |
Apr
|
pubmed:issn |
0004-4172
|
pubmed:author | |
pubmed:issnType |
Print
|
pubmed:volume |
47
|
pubmed:owner |
NLM
|
pubmed:authorsComplete |
Y
|
pubmed:pagination |
528-30
|
pubmed:dateRevised |
2004-11-17
|
pubmed:meshHeading |
pubmed-meshheading:9205758-Administration, Oral,
pubmed-meshheading:9205758-Adult,
pubmed-meshheading:9205758-Benzenesulfonates,
pubmed-meshheading:9205758-Half-Life,
pubmed-meshheading:9205758-Histamine H2 Antagonists,
pubmed-meshheading:9205758-Humans,
pubmed-meshheading:9205758-Male,
pubmed-meshheading:9205758-Thiazoles
|
pubmed:year |
1997
|
pubmed:articleTitle |
Tolerability and pharmacokinetics of ebrotidine in healthy subjects given single and repeated oral doses.
|
pubmed:affiliation |
Department of Pharmacology and Toxicology, Institut Municipal d'Investigació Mèdica, Universitat Autònoma de Barcelona, Spain.
|
pubmed:publicationType |
Journal Article
|