Phase I study of propiverine hydrochloride. The 2nd Report. Repeated oral dosing study.:The 2nd Report: Repeated Oral Dosing Study

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Phase I study of propiverine hydrochloride (P-4), a new antispasmodic and anticholinergic drug, was performed in healthy adult male volunteers to investigate its safety and pharmacokinetics. P-4 was administered orally in repeated doses of 20, 30, and 40 mg twice daily after meals for 5 or 7 days (five volunteers in each group). The study was a doubleblind trial and placebo was administered to two or three volunteers as control. The doses were increased step by step after the safety of the compound was confirmed.<BR>No apparent changes were noted in vital signs, ECGs or laboratory tests. As to subjective symptoms, anticholinergic-like subjective symptoms were observed at the 40 mg/day dose levels. They were, however, very mild and transient.<BR>P-4 and its metabolites were detected in plasma and urine after continuous administration.<BR>The measured plasma levels reached steady states on the 4th day of administration.
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