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■JPT-online■
1993
Issue Vol.21 no.6 (159-168)
Title A phase I study of granisetron hydrochloride(1)-The safety of single oral administration in healthy Japanese subjects-
Author H.Sekino et al.

A single oral administration study of the anti-emetic, granisetron hydrochloride at 5, 10 and 20 mg was conducted in 16 Japanese healthy male subjects as a phase I study with a placebo controlled double-blind manner to assess the safety of this drug. The result of this study was as follows:

1) Some cases of constipation were observed in after single oral administration. They, however, were slight and recovered rapidly after leaving hospital. Any other symptoms attributed to the drug were not observed.

2) In this phase I study, granisetron hydrochloride was well-tolerated in healthy Japanese male subjects.