Source:http://linkedlifedata.com/resource/pubmed/id/12520631
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
2003-1-10
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pubmed:abstractText |
The pharmacokinetics and intragastric pH effects of a novel nizatidine controlled-release (CR) formulation were compared to a currently marketed immediate-release (IR) nizatidine formulation (Axid). The bimodal pulsatile release characteristics of nizatidine CR decreased its Cmax by approximately 42% compared to nizatidine IR while maintaining 90% relative bioavailability; tmax was approximately 1.6 times longer with the CR formulation. These characteristics enabled controlled-release nizatidine to sustain effective plasma drug concentrations for a greater duration than immediate-release nizatidine over the dosing intervals. In multiple doses, the 24-hour AUC ratio for all comparisons of nizatidine CR 150 mg bid, nizatidine CR 300 mg daily, and nizatidine IR 150 mg bid was between 97% and 99%. Mean pH AUC values for nizatidine CR 150 mg bid and nizatidine IR 150 mg bid were similar overall during the 0- to 14-hour and 14- to 24-hour dosing intervals. For the 14- to 24-hour dosing interval, nizatidine CR 150 mg maintained gastric pH over 3.0 and 4.0 for 42% and 27% of the time compared to 39% and 23% for nizatidine IR, respectively. Nizatidine CR 300 mg, compared to the 150-mg CR and IR regimens, had a greater effect on increasing evening intragastric pH, thus providing support for the potential utility of nizatidine CR 300 mg dosed at night in alleviating nocturnal symptoms of gastroesophageal reflux disease.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Jan
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pubmed:issn |
0091-2700
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
43
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
74-83
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:12520631-Adolescent,
pubmed-meshheading:12520631-Adult,
pubmed-meshheading:12520631-Cross-Over Studies,
pubmed-meshheading:12520631-Delayed-Action Preparations,
pubmed-meshheading:12520631-Female,
pubmed-meshheading:12520631-Histamine H2 Antagonists,
pubmed-meshheading:12520631-Humans,
pubmed-meshheading:12520631-Male,
pubmed-meshheading:12520631-Middle Aged,
pubmed-meshheading:12520631-Nizatidine
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pubmed:year |
2003
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pubmed:articleTitle |
Pharmacokinetics and pharmacodynamics of a novel nizatidine controlled-release formulation in healthy subjects.
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pubmed:affiliation |
Buffalo Clinical Research Center, LLC, 1275 Delaware Avenue, 2nd Floor, Buffalo, NY 14209, USA.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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