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

NCT06211283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-01-22

No results posted yet for this study

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.

Conditions

  • Food-drug Interaction

Interventions

DRUG

Sodium valproate

fasted

DRUG

Sodium valproate

fed

Sponsors & Collaborators

  • BioPharma Services Inc.

    collaborator INDUSTRY

  • Desitin Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor, MD · BioPharma Services Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06211283 on ClinicalTrials.gov