生物学的同等性とバイオアベイラビリティのジャーナル

概要

Single-Dose, Open-Label, One-Way Pharmacokinetic Studies In The Mexican Population To Evaluate The Bioavailability And Food Effect On The Pharmacokinetics Of 30-mg Extended-Release Nifedipine Tablets

Alberto Martínez-Muñoz, Karen Nathalie Geraldo-Bastida, Alondra Nataly Lobatos-Buenrostro, Juan Luis Gutiérrez-Velázquez, Carlos Joel Salas-Montantes, Héctor Manuel González-Martínez, Araceli Guadalupe Medina-Nolasco, Porfirio de la Cruz-Cruz, Sandra Lara-Figueroa, Ricardo Zamora-Ramírez, José Luis Rubio-Santiago

The nifedipine immediate-release formulation has been associated with reflex sympathetic nervous system activation leading to several adverse effects such as flushing, tachycardia, worsening myocardial ischemia, and cerebrovascular ischemia. Development of a modified-release formulation represents a challenge, particularly the development of a once-daily formulation. Therefore, these studies evaluated the pharmacokinetic profile of a new 30-mg Extended-Release Nifedipine Tablets in Mexican population. The formulation [ANHITEN-A®] was manufactured by Ultra Laboratorios S.A. de C.V. [Jalisco, Mexico] with number of batch 9JN134A and expiration date September 2021.