• YAKHAK HOEJI
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• v.37 no.5
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• pp.442-452
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• 1993

Previous experimental and clinical investigations suggest a possible role of new nootropic drug, oxiracetam, in improving cognitive performances in patients affected by organic brain syndrome. In this study, the cognitive and behavioral effects of oxiracetam treatment in patients with clinical symptoms of organic brain syndrome were evaluated. Sixty-six patients were enrolled and assigned to either oxiracetam or placebo, according to a randomized, double-blind design between two patient-groups. Either oxiracetam or placebo was orally given bid for 8 weeks ; daily dose of oxiracetam was 1600mg. All the patients, enrolled in this study, were diagnosed as having mild to moderate cognitive dysfunction as defined by a baseline Mini Mental State ExaminationKorean version (MMSE-K) score between 14 and 25. The patients under-went, at baseline, 4 weeks and 8 weeks after, routine laboratory study (CBC, SMA12, U/A, EKG) and the following neuropsychological tests ; MMSE-K, modified Korean Wechsler Intelligence Scale(MKWIS), Nurses' Observation Scale for Geriatric patients(NOSGER). Fifteen patients of whom were dropped out or excluded from the analysis because of poor compliance or violation of the protocol. Fiftyone patients (aged 54~78 years, male 25, female 26) were analyzed (vascular dementia, 30 ; senile dementia of Alzheimer type, 9 ; mixed type, 5 ; other cause, 7). Statistical analysis of the data demonstrated that the two groups were comparable at baseline. At the end of each study period the oxiracetam group scored significantly better on the majority of the tests evaluating cognitive function, psychometricity and the improvement rating scale of subjective symptoms than placebo group, in which worsening trends or no changes were seen on the whole. No side effects were noted during oxiracetam treatment. The present study, showing positive clinical findings after oxiracetam therapy, confirmed that this drug can be useful pharmacological treatment in organic brain syndrome.

• Analytical Science and Technology
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• v.23 no.6
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• pp.587-594
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• 2010

This study aims to determine that the test of medicines containing oxiracetam as their main ingredient was properly performed according to protocol. Furthermore, the study is to provide the written form of protocol in order to examine the validity of the HPLC analytical method for the quantitative analysis of oxiracetam in the finished products. In this experiment, system suitability, precision, linearity, range, accuracy, specificity, quantitative limit, and detection limit of the analytical method which was used to determine the contained quality of oxiracetam, were examined. The result shows that system suitability indicates 0.127% RSD, plate number 15081, tailing factor 0.49, and resolution 32.41. The experiment of precision reveals the result of below 0.359% for repetitiveness and among the subjects. In the linearity experiment, a coefficient of correlation ($R^2$) indicates that it is 1. The accuracy experiment satisfies the standards of the recovery test, which is minimum 98.4% and maximum 99.6%. Detection limit is 0.1 mg/L and quantitative limit was found to be 0.5 mg/L. The experiment to check the specificity also satisfies the standards, so the finished product using oxiracetam as the main ingredient is verified as suitable.

• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.215-222
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• 2004

The purpose of the present study was designed to evaluate the bioequivalence of two oxiracetam tablets, Neuromed tablet (Korea Drug Co., reference drug) and Neuracetam tablet (Sam Jin Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Release of oxiracetam from the tablet in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty-four healthy volunteers, $23.7\;{\pm}\;2.4$ year in age and $68.9\;{\pm}\;6.2$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 800 mg of oxiracetam, blood samples were taken at predetermined time intervals and concentrations of oxiracetam in plasma were determined using HPLC-MS-MS. The dissolution profiles of two formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug were 0.42%, 0.45% and -12.58% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{\sim}log1.06$ and $log0.90{\sim}log1.07$ for $AUC_t$, and $C_{max}$, respectively), indicating that Neuracetam tablet is bioequivalent to Neuromed tablet. The major pharmacokinetic parameters, $AUC_t$, and $C_{max}$ met the criteria set by KFDA for bioequivalence indicating that Neuracetam tablet is bioequivalent to Neuromed tablet.