Abstract
A Phase l study on cisapride (R 51 619), a new gastrointestinal prokineti cagent, was conducted in 7 healthy Japanese male volunteers.The safety and phafmacokinetics of the drug were studied in single intravenous doses of 2 and 4 mg.
The 2 men of group 1 received 2 mg, and the remaining 5 men (group2) were given 4 mg.
There were no complaints about subjective symptoms.No abnormalities were seen in ECGs or laboratory tests.Among vital signs, a rise of pulse rate was observed after the 4 mg dosing.
The time-concentration curves of cisapride could be fitted into a three compartment open model.The half-life of the unchanged drug in the π-phase, the α-phase, and the β-phase rate was 0.032, 0.90 and 6.4 hours respectively.
The above results confirmed the safety of cisapride in single intravenous dosing in healthy male vorunteers.
