Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets
Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Bioavailability is the extent and rate to which the active drug ingredient or active moiety
from the drug product is absorbed and becomes available at the site of drug action.
Bioavailability of an active substance delivered from a pharmaceutical product should be
known and reproducible. In the past, several therapeutic misadventures related to differences
in bioavailability affirm to the necessity of testing the performance of dosage forms in
delivering the active substance to the systemic circulation and thereby to the site of
action. If there is no clinically significant difference in the bioavailability of two
medicines they are considered to be bioequivalent.
The bioavailability and bioequivalence studies of various drug candidates have been routine
regulatory requirements in many countries for licensing of the drug product. Department of
Drug Administration, Ministry of health and Population has encouraged Nepalese Pharmaceutical
Industries legally to submit pharmacokinetic data where possible for licensing purpose for
certain drug candidates and their dosage forms. The comparative in-vivo bioequivalence study
is necessary for those products which have low therapeutic index, low bioavailability,
non-linear kinetics, poor dissolution profile, variable bioavailability and/or
bioequivalence. Department of Drug Administration necessitated bioequivalence and
bioavailability study for the modified release dosage form of those drug molecules whose
blood steady state concentration is of great importance, e.g. sodium valproate, valproic
acid, carbamazepine, antibiotics etc. Considering the need to confirm safety and
effectiveness of the medications and also for the regulatory requirement, this study to
assess the bioequivalence of sodium valproate and valproic acid extended release tablet
manufactured by a Nepalese pharmaceutical company, Asian Pharmaceuticals Pvt. Ltd., with an
innovator formulation is being carried out in healthy human volunteers.