Ondansetron absorption in adults: Effect of dosage form, food, and antacids

✍ Scribed by Haig P. Bozigian; J. Frederick Pritchard; Ann E. Gooding; Gary E. Pakes

• Publisher: John Wiley and Sons
• Year: 1994
• Tongue: English
• Weight: 360 KB
• Volume: 83
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.2600830717

✦ Synopsis

Ondansetron is a competitive serotonin 5-HT3 receptor blocker that has proved useful in the prevention of emesis due to cisplatin and other cancer chemotherapeutic agents. I n a randomized, open-label, crossover study in 24 healthy male subjects, the relative bioavailability of a single 8-mg tablet was compared with that of an 8-mg solution using the two one-sided &tests. The tablet and solution formulations were bioequivalent, as confirmed by similarities in mean C, , (26.3 vs 27.7 ng/mL), T, , (1.79 vs 1.70 h), and AUC (166.0 vs 167.3 ng-h/mL)values. I n another randomized, open-label, crossover study in 12 healthy male subjects, the bioavailability of an 8-mg ondansetron tablet administered 5 min after a standard meal was slightly but significantly greater than in fasted subjects, as indicated by comparative mean AUC values [201.4 ng-h/mL (fed) vs 172.5 ng.h/mL (fasted)]. Coadministration of a magnesium hydroxide/ aluminum hydroxide antacid did not affect the bioavailability of the ondansetron tablet.