Objectives:
Today, biological equivalence studies what in terms of acquisitions and the survival of invitro quality of drug product and how statistical equality rate and the amount of bioavailability with the world's most reliable pharmaceutical product market (reference) are remarkable importance
In our country, in recent decades also seeks to establish a new system of medical management, particular attention to the issue of biological equivalence. So different groups of researchers at medicinal universities and the private sector carry out tests of bioequivalency for market products.
This study as part of the domestically program of bio-equivalence tests, was carried out to assess the equivalence of gabapentin 300 mg capsules produced in Sobhan Daru company compare to a reference product.
Design: plan consists of two independent parts, invitro tests, with the aim of evaluating the quality of the test and reference products based on pharmacopoeia standards and after approval, invivo studies on 24 volunteer with the aim of providing the rate and amount of bioavailability.
Inclusion criteria:
24 healthy male and female volunteers, average age of 18 to 45 years, based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes; lack of any chronic or acute medication at least 1 week before the start of the study
Interventions:
single-dose of two formulations containing 300 mg gabapentin (Sobhan daru and reference) administrate to the volunteers in an open, randomized, crossover, 2 periods x 2 sequences, with a minimum washout period of 7 days. Blood sampling was taken at the designated times, and drug was extracted by liquid extraction method and analyzed by HPLC instrument and UV detection.
Main outcome variables:
From plasma concentration- time curves and pharmacokinetic models, all drug kinetic parameters in both formulations were calculated and biological equivalency of two formulations was evaluated.