Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets

Launched by KATHMANDU UNIVERSITY · Dec 6, 2022

Keywords

ClinConnect Summary

Successful therapeutic management of patients with epilepsy requires selection of an appropriate antiepileptic regimen, optimal dosing and patient compliance. Valproate is primarily used to treat epilepsy and bipolar disorder. Valproate exists in two main molecular variants; sodium valproate and valproic acid. These molecules have been widely used in the last decade and is now considered as relatively safe and effective anticonvulsant agents. These drug molecules were registered in Department of Drug administration of Nepal long time back.

The mechanism of action of valproate is not clear....

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 - 60 years.
• • 2. Gender: Male / female or both
• • 3. Weight: At least 50 kg (110 lbs) and within 15% of Ideal Body Weight (IBW). BMI between 18.0 and 29.9 kg/m², inclusive
• • 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, including vital signs, laboratory evaluations, 12-lead ECG, hepatitis B, hepatitis C and HIV tests) performed within 14 days of the initial dose of study medication.
• • 5. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained
• Exclusion Criteria:
• 1. Social Habits:
• • i. Use of any tobacco products within month of the start of the study. ii. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within 48 hours prior to the initial dose of study medication.
• • iii. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• • iv. Any recent, significant change in dietary or exercise habits. v. History of drug and/or alcohol abuse.
• 2. Medications:
• • i. Use of any prescription or over-the-counter (OTC) medications within 14 days prior to the initial dose of study medication.
• • ii. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• 3. Diseases:
• • i. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
• • ii. Acute illness at the time of either the pre-study medical evaluation or dosing.
• • iii. A positive HIV, hepatitis B, or hepatitis C tests.
• 4. Abnormal and clinically significant laboratory test results:
• • i. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities.
• • ii. Abnormal and clinically relevant ECG tracing.
• • 5. Clinical Studies i. Participation in any clinical study (inclusive of final post-study examination) within the 12 weeks before screening visit.
• • ii. Subject whose participation in this study will result in a participation in more than four studies over a twelve month period.
• • 6. Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
• • 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
• • 8. Allergy or hypersensitivity to valproic acid / sodium valproate or any other related products.
• • 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
• • 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Trial Officials