Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets
brief summary
Comparative bioavailability of valproate from Orfiril long 500 mg prolonged-release mini-tablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting conditions.
detailed description
Pivotal, multiple-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, study designed to evaluate the comparative bioavailability of valproate for Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablet once daily for 6 days in healthy male subjects under fasting conditions.
official title
Multiple-dose, Randomized, Open-Label, Fasting, Two-period, Crossover, Bioavailability Study Between Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets in Healthy, Male Volunteers.