Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects
Identifieur interne : 00E602 ( Main/Exploration ); précédent : 00E601; suivant : 00E603Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects
Auteurs : Robert J. Wills [États-Unis] ; Nadia Choma [États-Unis] ; Gerard Buonpane [États-Unis] ; Amy Lin [États-Unis] ; Nancy Keigher [États-Unis]Source :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 1987-12.
English descriptors
- Teeft :
- Adverse experiences, Agents chemother, Bioavailability, Blood samples, Clinical consequence, Cmax, Corresponding values, Drug administration, Hayden, Healthy adults, Healthy subjects, Maximum concentration, Maximum concentrations, Oral solution, Pharmaceutical sciences, Pharmacokinetic, Pharmacokinetic parameters, Physical examination, Plasma concentration point, Plasma data, Present study, Randomized crossover design, Relative bioavailability, Rimantadine, Rimantadine plasma concentrations, Significant differences, Single dose, Single doses, Syrup, Tablet, Water washings.
Abstract
Twenty healthy male subjects completed an open‐label randomized crossover design to assess the bioavailability of 100 mg of rimantadine HCl in tablet and syrup forms relative to an oral solution. Blood samples were drawn and rimantadine plasma concentrations were determined by a GC‐MS method. The maximum plasma concentration (Cmax), the time to Cmax (tmax), the area under the plasma concentration—time curve (AUC), and k were compared among treatments using an analysis of variance and the Hauck—Anderson test for bioequivalence. The Hauck—Anderson test was satisfied when the syrup and solution were compared. The relative bioavailability of the syrup was 96%. Both Cmax and AUC were significantly (p < 0.05) increased (23 and 17%, respectively) when the tablet was compared with the solution. The relative bioavailability of the tablet was 117%. This outcome was unusual and could not be explained. However, this was not anticipated to be of clinical consequence since the majority of the safety and efficacy of rimantadine HCl was established using a tablet.
Url:
DOI: 10.1002/jps.2600761208
Affiliations:
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Blood samples were drawn and rimantadine plasma concentrations were determined by a GC‐MS method. The maximum plasma concentration (Cmax), the time to Cmax (tmax), the area under the plasma concentration—time curve (AUC), and k were compared among treatments using an analysis of variance and the Hauck—Anderson test for bioequivalence. The Hauck—Anderson test was satisfied when the syrup and solution were compared. The relative bioavailability of the syrup was 96%. Both Cmax and AUC were significantly (p < 0.05) increased (23 and 17%, respectively) when the tablet was compared with the solution. The relative bioavailability of the tablet was 117%. This outcome was unusual and could not be explained. However, this was not anticipated to be of clinical consequence since the majority of the safety and efficacy of rimantadine HCl was established using a tablet.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>New Jersey</li></region></list><tree><country name="États-Unis"><region name="New Jersey"><name sortKey="Wills, Robert J" sort="Wills, Robert J" uniqKey="Wills R" first="Robert J." last="Wills">Robert J. Wills</name></region><name sortKey="Buonpane, Gerard" sort="Buonpane, Gerard" uniqKey="Buonpane G" first="Gerard" last="Buonpane">Gerard Buonpane</name><name sortKey="Choma, Nadia" sort="Choma, Nadia" uniqKey="Choma N" first="Nadia" last="Choma">Nadia Choma</name><name sortKey="Keigher, Nancy" sort="Keigher, Nancy" uniqKey="Keigher N" first="Nancy" last="Keigher">Nancy Keigher</name><name sortKey="Lin, Amy" sort="Lin, Amy" uniqKey="Lin A" first="Amy" last="Lin">Amy Lin</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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