NCT06214130

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Drug Use

Interventions

Type	Name	Description
DRUG	Sodium valproate 500 MG	oral intake
DRUG	Valproic Acid 500 MG	oral intake

Timeline

• Start date: 2023-09-22
• Primary completion: 2023-11-06
• Completion: 2023-11-18
• First posted: 2024-01-19
• Last updated: 2024-01-23

Locations

1 site across 1 country: Canada