Alpha-D-Galactosidase does not Interfere with Trimebutine Oral Pharmacokinetics in Mexican Healthy Volunteers
- *Corresponding Author:
- López-Sánchez P, MD, PhD
Graduate Studies and Research Section
School of Medicine of the National Polytechnic Institute
Plan of San Luis and Diaz Miron s/n
Col. Casco de Sto. Tomás, C.P. 11340, Mexico
E-mail: [email protected]
Received Date: May 17, 2017; Accepted Date: June 09, 2017; Published Date: June 16, 2017
Citation: Peñaloza-Becerra CA, Ortega-Escamilla E, Vásquez JEV, Marcelín- Jiménez G, Ángeles AP, et al. (2017) Alpha-D-Galactosidase does not Interfere with Trimebutine Oral Pharmacokinetics in Mexican Healthy Volunteers. J Bioequiv Availab 9:447-451. doi: 10.4172/jbb.1000342
Copyright: © 2017 Peñaloza-Becerra CA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Gas production is a common symptom in bowel affections. There are different formulations to improve general symptoms, including motility regulators, such as trimebutine, and surfactants, such as simethicone, or both. These approaches, however, do not affect gas production. Methane, hydrogen, carbon dioxide, and water are generated in the intestines due to action of bacterial flora on non-digestible carbohydrates from the diet. The unfolding of these carbohydrates by specific enzymes promises greater improvement of symptomatology. Alpha-D-Galactosidase degrades these carbohydrates from diet. It is not known whether the addition of this enzyme modifies trimebutine pharmacokinetics. Thus, our aim was to assess whether the addition of Alpha-D-Galactosidase to a commercial formulation alters trimebutine oral pharmacokinetics. We conducted a controlled, cross-over, randomized, simpleblind, two-period, two-treatment, and two-sequence clinical trial on 30 healthy Mexican volunteers, receiving a single dose of reference product and test product. Pharmacokinetics and safety of usage were obtained. We measured N-desmethyl-trimebutine, the major metabolite of trimebutine. We showed that addition of galactosidase does not modify any pharmacokinetic parameter significantly. Safety of the subjects was not affected. We conclude that alpha-D-Galactosidase does not modify oral pharmacokinetics of trimebutine, rendering this approach suitable for commercial use in indicated bowel affections.