Comparison of the pharmacokinetics of a new 30 mg modified-release tablet formulation of metoclopramide for once-a-day administration versus 10 mg immediate-release tablets: a single and multiple-dose, randomized, open-label, parallel study in healthy male subjects.

The study aimed to assess the pharmacokinetics of a new, modified-release metoclopramide tablet, and compare it to an immediate-release tablet. A single and multiple-dose, randomized, open-label, parallel, pharmacokinetic study was conducted. Investigational products were administered to 26 healthy Hispanic Mexican male volunteers for two consecutive days: either one 30 mg modified-release tablet every 24 h, or one 10 mg immediate-release tablet every 8 h.

Comparison of the pharmacokinetics of a new 15-mg modified-release tablet formulation of metoclopramide versus a 10-mg immediate-release tablet: a single- and multiple-dose, randomized, open-label, parallel-group study in healthy Mexican male volunteers.

Background: Metoclopramide is a prokinetic and antiemetic agent.

Objective: The goal of this study was to assess the pharmacokinetics of a new, modified-release metoclopramide tablet and compare it with an immediate-release tablet to obtain marketing approval from the Mexican regulatory agency.

Methods: This was a single-center, randomized, open-label, parallel-group, single- and multiple-dose, pharmacokinetic study.