NCT06211283

Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.

Single Dose, Open-label, Four-way, Fed-fasted Crossover, Comparative Bioavailability and Food Effect of Orfiril Long 500 mg Prolonged Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets in Healthy Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting and fed conditions.

Detailed description

This was a pivotal, single dose, randomized, open-label, four-period, four-sequence, four-treatment, single-centre, four-way crossover design, food effect and comparative bioavailability study of Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, non-smoking, male subjects under fasting and fed conditions. Subjects were randomly assigned to one of the four dosing sequences.

Conditions

• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	Sodium valproate	fasted
DRUG	Sodium valproate	fed

Timeline

• Start date: 2023-09-11
• Primary completion: 2023-10-20
• Completion: 2023-11-01
• First posted: 2024-01-18
• Last updated: 2024-01-22

Locations

1 site across 1 country: Canada