Source:http://linkedlifedata.com/resource/pubmed/id/11865971
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
3
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pubmed:dateCreated |
2002-2-27
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pubmed:abstractText |
A multiple-dose, placebo-controlled, randomized pharmacokinetic study was performed in 15 early (i.e., 1-3 years) postmenopausal women to evaluate the single and steady-state pharmacokinetics of 0.625 mg Cenestin (Synthetic Conjugated Estrogens, A) tablets, administered once daily for 90 days. Plasma concentration-time profiles for both total (conjugated and unconjugated) estrone and equilin, two major estrogens in Cenestin, were nearly superimposable between Day 1 (single dose) and Day 90 (multiple dose), indicating equivalent drug exposure from one dose to the next. For total estrone, the mean estimates of Cmax and AUC0-24 were 2.5 ng/ml and 35.0 ng x h/ml for Day 1 and 3.0 ng/ml and 39.8 ng x h/ml for Day 90, respectively. Similarly, Cmax and AUC0-24 mean values for total equilin were 1.4 ng/ml and 17.4 ng x h/ml after Day 1 and 1.5 ng/ml and 17.3 ng x h/ml after Day 90, respectively. The mean tmax value for total estrone was 8.3 hours on Day 1 and 8.6 hours on Day 90, indicating a slower rate of absorption. The average estimate for observed drug accumulation index for the 24-hour dosing interval was calculated to be 1.1 for total estrone and 1.0 for total equilin. These data, taken together, indicate a slow and steady rate of absorption, minimal drug accumulation at steady state, and consistent drug exposure between Cenestin doses.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Delayed-Action Preparations,
http://linkedlifedata.com/resource/pubmed/chemical/Equilin,
http://linkedlifedata.com/resource/pubmed/chemical/Estradiol,
http://linkedlifedata.com/resource/pubmed/chemical/Estradiol Congeners,
http://linkedlifedata.com/resource/pubmed/chemical/Estrogens, Conjugated (USP),
http://linkedlifedata.com/resource/pubmed/chemical/Estrone,
http://linkedlifedata.com/resource/pubmed/chemical/Tablets,
http://linkedlifedata.com/resource/pubmed/chemical/estrogens, conjugated synthetic A
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pubmed:status |
MEDLINE
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pubmed:month |
Mar
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pubmed:issn |
0091-2700
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
42
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
332-41
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:11865971-Adult,
pubmed-meshheading:11865971-Aged,
pubmed-meshheading:11865971-Area Under Curve,
pubmed-meshheading:11865971-Delayed-Action Preparations,
pubmed-meshheading:11865971-Double-Blind Method,
pubmed-meshheading:11865971-Equilin,
pubmed-meshheading:11865971-Estradiol,
pubmed-meshheading:11865971-Estradiol Congeners,
pubmed-meshheading:11865971-Estrogen Replacement Therapy,
pubmed-meshheading:11865971-Estrogens, Conjugated (USP),
pubmed-meshheading:11865971-Estrone,
pubmed-meshheading:11865971-Female,
pubmed-meshheading:11865971-Humans,
pubmed-meshheading:11865971-Middle Aged,
pubmed-meshheading:11865971-Postmenopause,
pubmed-meshheading:11865971-Tablets
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pubmed:year |
2002
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pubmed:articleTitle |
Evaluation of single- and multiple-dose pharmacokinetics of synthetic conjugated estrogens, A (Cenestin) tablets: a slow-release estrogen replacement product.
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pubmed:affiliation |
Department of Clinical & Medical Affairs, Barr Research, Inc., Cincinnati, OH 45213, USA.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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