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

Food-drug Interaction Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06211283
Study type Interventional
Source Desitin Arzneimittel GmbH
Contact
Status Completed
Phase Phase 1
Start date September 11, 2023
Completion date November 1, 2023
View Details
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