Linked Life Data

15703367

Source:http://linkedlifedata.com/resource/pubmed/id/15703367

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2005-2-10
pubmed:abstractText
This study was undertaken to evaluate the effect of dexloxiglumide, a selective cholecystokinin receptor antagonist, on the pharmacokinetics of a combination oral contraceptive (OC). A single-blind, placebo-controlled, 2-period crossover study was conducted in 24 healthy young female subjects who received Ortho Tri-Cyclen containing ethinyl estradiol (EE, 0.035 mg) and norgestimate (NE, 0.180 mg/0.215 mg/0.250 mg per 7-day phase, respectively) for 5 days (days 17-21) concurrently with either 200 mg dexloxiglumide (3 times a day on days 17-20, followed by a single dose on day 21) or matching placebo during 2 consecutive 28-day OC dosing cycles. Plasma was sampled up to 24 hours for the determination of EE, NE, and 17-deactyl norgestimate (17-DNE, a rapidly formed pharmacologically active metabolite of NE). The geometric mean ratios (GMRs, dexloxiglumide/placebo) of the plasma concentration-time curve over 24 hours with corresponding 90% confidence intervals (CIs) for EE and 17-DNE were 1.21 (1.17-1.26) and 0.92 (0.89-0.95), respectively. The GMRs (90% CI) of C(max) for EE and 17-DNE were 1.15 (1.09-1.20) and 0.93 (0.90-0.96), respectively. Coadministration of OC and dexloxiglumide was well tolerated and safe. Comparable systemic exposure of EE and 17-DNE in the presence and absence of dexloxiglumide suggests that dexloxiglumide treatment is unlikely to interfere with the safety and efficacy of oral contraceptives based on the analysis of the resulting pharmacokinetic profile.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
http://linkedlifedata.com/resource/pubmed/chemical/CYP3A protein, human, http://linkedlifedata.com/resource/pubmed/chemical/Contraceptives, Oral, Synthetic, http://linkedlifedata.com/resource/pubmed/chemical/Cytochrome P-450 CYP3A, http://linkedlifedata.com/resource/pubmed/chemical/Cytochrome P-450 Enzyme System, http://linkedlifedata.com/resource/pubmed/chemical/Ethinyl Estradiol, http://linkedlifedata.com/resource/pubmed/chemical/Levonorgestrel, http://linkedlifedata.com/resource/pubmed/chemical/Norgestrel, http://linkedlifedata.com/resource/pubmed/chemical/Pentanoic Acids, http://linkedlifedata.com/resource/pubmed/chemical/Receptors, Cholecystokinin, http://linkedlifedata.com/resource/pubmed/chemical/dexloxiglumide, http://linkedlifedata.com/resource/pubmed/chemical/levonorgestrel oxime, http://linkedlifedata.com/resource/pubmed/chemical/norgestimate, ethinyl estradiol...
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0091-2700
pubmed:author
pubmed:issnType
Print
pubmed:volume
45
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
329-36
pubmed:dateRevised
2010-11-18
pubmed:meshHeading
pubmed:year
2005
pubmed:articleTitle
Effect of multiple-dose dexloxiglumide on the pharmacokinetics of oral contraceptives in healthy women.
pubmed:affiliation
Department of Clinical Pharmacology and Drug Dynamics, Forest Research Institute, Harborside Financial Center, Plaza V, Jersey City, NJ 07311, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial