Phase I study of propiverine hydrochloride. The 1st report. Single oral dosing study.:The 1st Report: Single Oral Dosing Study

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Phase I study of propiverine hydrochloride (P-4), a new anticholinergic and antispasmodic drug, was performed in healthy adult male volunteers to investigate its safety and pharmacokinetics. P-4 was administered orally in single doses of 5, 10, 15, and 20 mg (six volunteers in each group). The doses were increased step by step after the safety of the compound was confirmed. No pronounced changes were noted in vital signs, ECGs, or laboratory tests. Subjective symptoms were observed at the 15 and 20 mg dose levels. But they were very mild and transient.<BR>P-4 and its metabolites were detected in plasma and urine after oral administration. Peak plasma levels of P-4 were found about 1-2 hr.<BR>Dose-dependency was observed in the plasma concentration (C<SUB>max</SUB>, AUC).
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