Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets

Multiple Drug Use Clinical Trial

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.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Multiple Drug Use

• NCT number: NCT06214130
• Study type: Interventional
• Source: Desitin Arzneimittel GmbH
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2023
• Completion date: November 18, 2023