Matches in SemOpenAlex for { <https://semopenalex.org/work/W1991391113> ?p ?o ?g. }
Showing items 1 to 94 of
94
with 100 items per page.
- W1991391113 endingPage "1031" @default.
- W1991391113 startingPage "1026" @default.
- W1991391113 abstract "Studies were conducted to establish the safety, tolerability, and pharmacokinetics of the antiepileptic drug (AED) ganaxolone. Ganaxolone belongs to a novel class of neuroactive steroids called epalons, which specifically modulate the gamma-aminobutyric acid type A (GABA[A]) receptor in the central nervous system (CNS). Chemically related to progesterone but devoid of any hormonal activity, the epalons have potent antiepileptic, anxiolytic, sedative, and hypnotic activities in animals.Ninety-six healthy male and female volunteers received ganaxolone in a variety of formulations, doses, and dosing regimens. The pharmacokinetics of ganaxolone were systematically characterized, and adverse events associated with drug use were documented.Ganaxolone was well tolerated after single doses (< or =1,500 mg) and after multiple doses (< or =300 mg b.i.d. for 10 days). Steady-state plasma levels (trough) occurred after approximately 7 days of dosing, with mean steady-state plasma concentrations (Cmax) in multiple dose studies of between 32 ng/ml (50-mg doses) and 376 ng/ml (500-mg doses). No serious or life-threatening adverse events attributed to the drug were observed. The majority of adverse events reported were mild (82%) to moderate (14%) and were limited to headache, dizziness, somnolence, gastrointestinal disturbances, and malaise.Ganaxolone alone or formulated with pharmaceutical-grade excipients is rapidly absorbed from the gastrointestinal tract after oral administration in doses ranging from 50 to 1,500 mg. Pharmacokinetic analysis revealed a linear and proportional increase in the area under the curve (AUC) and Cmax values with increasing dose within the expected therapeutic dose range. Safety and tolerability in the clinical program were unremarkable." @default.
- W1991391113 created "2016-06-24" @default.
- W1991391113 creator A5020712877 @default.
- W1991391113 creator A5024134098 @default.
- W1991391113 creator A5026437025 @default.
- W1991391113 creator A5055395796 @default.
- W1991391113 creator A5090510588 @default.
- W1991391113 date "1997-09-01" @default.
- W1991391113 modified "2023-10-18" @default.
- W1991391113 title "Initial Human Experience with Ganaxolone, a Neuroactive Steroid with Antiepileptic Activity" @default.
- W1991391113 cites W1997047517 @default.
- W1991391113 cites W2077468380 @default.
- W1991391113 doi "https://doi.org/10.1111/j.1528-1157.1997.tb01486.x" @default.
- W1991391113 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/9579942" @default.
- W1991391113 hasPublicationYear "1997" @default.
- W1991391113 type Work @default.
- W1991391113 sameAs 1991391113 @default.
- W1991391113 citedByCount "111" @default.
- W1991391113 countsByYear W19913911132012 @default.
- W1991391113 countsByYear W19913911132013 @default.
- W1991391113 countsByYear W19913911132014 @default.
- W1991391113 countsByYear W19913911132015 @default.
- W1991391113 countsByYear W19913911132016 @default.
- W1991391113 countsByYear W19913911132017 @default.
- W1991391113 countsByYear W19913911132018 @default.
- W1991391113 countsByYear W19913911132019 @default.
- W1991391113 countsByYear W19913911132021 @default.
- W1991391113 countsByYear W19913911132022 @default.
- W1991391113 countsByYear W19913911132023 @default.
- W1991391113 crossrefType "journal-article" @default.
- W1991391113 hasAuthorship W1991391113A5020712877 @default.
- W1991391113 hasAuthorship W1991391113A5024134098 @default.
- W1991391113 hasAuthorship W1991391113A5026437025 @default.
- W1991391113 hasAuthorship W1991391113A5055395796 @default.
- W1991391113 hasAuthorship W1991391113A5090510588 @default.
- W1991391113 hasBestOaLocation W19913911131 @default.
- W1991391113 hasConcept C112705442 @default.
- W1991391113 hasConcept C118552586 @default.
- W1991391113 hasConcept C126322002 @default.
- W1991391113 hasConcept C168258287 @default.
- W1991391113 hasConcept C170493617 @default.
- W1991391113 hasConcept C197934379 @default.
- W1991391113 hasConcept C22979827 @default.
- W1991391113 hasConcept C2776277131 @default.
- W1991391113 hasConcept C2777260365 @default.
- W1991391113 hasConcept C2777288759 @default.
- W1991391113 hasConcept C2777907850 @default.
- W1991391113 hasConcept C2778186239 @default.
- W1991391113 hasConcept C2778338918 @default.
- W1991391113 hasConcept C2778375690 @default.
- W1991391113 hasConcept C42219234 @default.
- W1991391113 hasConcept C44796713 @default.
- W1991391113 hasConcept C71924100 @default.
- W1991391113 hasConcept C98274493 @default.
- W1991391113 hasConceptScore W1991391113C112705442 @default.
- W1991391113 hasConceptScore W1991391113C118552586 @default.
- W1991391113 hasConceptScore W1991391113C126322002 @default.
- W1991391113 hasConceptScore W1991391113C168258287 @default.
- W1991391113 hasConceptScore W1991391113C170493617 @default.
- W1991391113 hasConceptScore W1991391113C197934379 @default.
- W1991391113 hasConceptScore W1991391113C22979827 @default.
- W1991391113 hasConceptScore W1991391113C2776277131 @default.
- W1991391113 hasConceptScore W1991391113C2777260365 @default.
- W1991391113 hasConceptScore W1991391113C2777288759 @default.
- W1991391113 hasConceptScore W1991391113C2777907850 @default.
- W1991391113 hasConceptScore W1991391113C2778186239 @default.
- W1991391113 hasConceptScore W1991391113C2778338918 @default.
- W1991391113 hasConceptScore W1991391113C2778375690 @default.
- W1991391113 hasConceptScore W1991391113C42219234 @default.
- W1991391113 hasConceptScore W1991391113C44796713 @default.
- W1991391113 hasConceptScore W1991391113C71924100 @default.
- W1991391113 hasConceptScore W1991391113C98274493 @default.
- W1991391113 hasIssue "9" @default.
- W1991391113 hasLocation W19913911131 @default.
- W1991391113 hasLocation W19913911132 @default.
- W1991391113 hasOpenAccess W1991391113 @default.
- W1991391113 hasPrimaryLocation W19913911131 @default.
- W1991391113 hasRelatedWork W2037651778 @default.
- W1991391113 hasRelatedWork W2051764329 @default.
- W1991391113 hasRelatedWork W2064759457 @default.
- W1991391113 hasRelatedWork W2074207917 @default.
- W1991391113 hasRelatedWork W2094883508 @default.
- W1991391113 hasRelatedWork W2319060667 @default.
- W1991391113 hasRelatedWork W3087516196 @default.
- W1991391113 hasRelatedWork W3151787567 @default.
- W1991391113 hasRelatedWork W3178697376 @default.
- W1991391113 hasRelatedWork W4292426920 @default.
- W1991391113 hasVolume "38" @default.
- W1991391113 isParatext "false" @default.
- W1991391113 isRetracted "false" @default.
- W1991391113 magId "1991391113" @default.
- W1991391113 workType "article" @default.