Phase I Clinical Study of a Phosphate binder, PB-94 (Sevelamer Hydrochloride)-Repeated Administration-

Accession number;03A0475552
Title;Phase I Clinical Study of a Phosphate binder, PB-94 (Sevelamer Hydrochloride)-Repeated Administration-
Author; MIWATANI HIROSHI (Yakusenkai Kannondaikurinikku) AKIZAWA TADAO (Showa Univ., Fujigaoka Hospital, JPN)
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.19;NO.6;PAGE.557-567(2003)
Figure&Table&Reference;FIG.2, TBL.7, REF.4
Pub. Country;Japan
Language;Japanese
Abstract;A phosphate binder, PB-94 was orally given at a daily dose of 4.5g or 9.0g three times daily for 7 consecutive days to healthy adult male volunteers. Placebo was also given in the same manner. No differences observed in serum phosphorus levels between the groups. A decrease in urinary phosphorus levels and an increase in cumulative phosphorus levels excreted in feces were confirmed. In laboratory data, decreases in T-Cho and LDL-Cho were observed; however, these are known variation that have already been reported in clinical studies overseas. It is concluded that there is no problem in developing the phosphate binder in dialysis patients with paying close attention to the variation of the above parameters. (author abst.)