[(14)C] Prucalopride after a Single Oral Dose in Healthy Volunteers.


eMediNexus Editorial    27 June 2018

Newer therapies to improve gastric motility include the selective 5-hydroxytryptamine receptor-4 agonist – prucalopride, which is licensed for the treatment of chronic constipation in adults.

A study published in Clinical Therapeutics investigated the tolerability of prucalopride after a single oral dose, in healthy volunteers.

In this single-period, open-label, nonrandomized study of [(14)C] prucalopride, 6 healthy men aged from 18 to 50 years were recruited. Participants were administered a single dose of [(14)C] prucalopride succinate 2 mg; subsequently, safety and adverse event data were collected.

The results showed that 100% of the administered dose was recovered, with a mean of 84.2% recovered in urine and 13.3% in feces. Moreover, prucalopride was found to be well tolerated, with no serious adverse events.

Hence, it was inferred that prucalopride was well tolerated in healthy adults and confers no serious adverse effects.

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