Articles Related to Study Design
Bioequivalence Study of Two Oral-Capsule Formulations of Omeprazole 20 mg in Combination with Sodium Bicarbonate in Healthy Mexican Adult Volunteers
In Mexico, the immediate-release formulation of omeprazole 20 mg in combination with 1100 mg of sodium bicarbonate (oral capsules) is indicated for patients over 18 years for the treatment of gastritis, reflux, heartburn and the sensation of emptiness caused by the excessive acid production.
Bioequivalence Study of Two Oral-Capsule Formulations of Pregabalin 300 mg in Healthy Mexican Adult Volunteers
Pregabalin is a ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system. It has anticonvulsant, analgesic, and anxiolytic activity. The bioequivalence of a test formulation was evaluated with respect to its corresponding reference drug formulation of oral pregabalin 300 mg, administered as a capsule. This randomized-sequence, single-dose, single-blind, two-period crossover design under fasting conditions was done on 25 healthy Mexican adult subjects including both genders. There was a seven-day washout period.