Clinical Pharmacokinetic Study of Talion Tablet (Bepotastine Besilate) in Nephropathic Patients (Post-Marketing Clinical Trial)
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Accession number;03A0475555
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| Title;Clinical Pharmacokinetic Study of Talion Tablet (Bepotastine Besilate) in Nephropathic Patients (Post-Marketing Clinical Trial) |
| Author;
KAWASHIMA KAZUTAKE
(Tanabe Seiyaku Co., Ltd.,JPN)
SAKAI MASAKI
(Tanabe Seiyaku Co., Ltd.,JPN)
TAKATSUKA SATOMI
(Tanabe Seiyaku Co., Ltd.,JPN)
TAGAWA KOZO
(Tanabe Seiyaku Co., Ltd.,JPN)
YANO SHINTARO
(Mitsuyakai Maebashihirosegawakurinikku)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.6;PAGE.637-648(2003)
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| Figure&Table&Reference;FIG.5, TBL.4, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The pharmacokinetics and safety of Talion (bepotastine besilate) 5mg-tablet on subjects with renal dysfunction were evaluated by an oral administration. 1) The pharmacokinetic parameters of the patients with mild renal impairment changed with those of the patients with normal renal function (controls). 2) In patients with moderate to severe renal impairment, the Tmax, t1/2 and AUC increased and the Cmax slightly increased compared with controls. 3) The renal clearance of bepotastine was decreased in the patients with impaired renal function, and it was significantly correlated to creatinin clearance. 4) When plasma concentration of repetitive oral administrations was predicted, Cmax of the stationary state of the patients with moderate to severe renal impairment was increased 1.8 folds compared with controls. Its safety is almost permitted, for it didn't exceed the plasma concentration. 5) Adverse events related to treatment in this clinical study were all slight abnormal changes in laboratory tests. In terms of the incidence of side effects no significant differences were observed in the three groups categorized by renal function (normal, mild, moderate to severe). In summary, Talion is satisfactory safety even in the patient with moderate to severe renal impairment when it is carefully administrated at the low dose (5mg). (author abst.) |
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