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

Phase 1 Completed 28 enrolled Desitin Arzneimittel GmbH BioPharma Services Inc. · collab

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2023-09-11
Primary completion: 2023-10-20
Completion: 2023-11-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valproate	Small molecule	500 mg	Oral

Indications

No indication recorded.