Tag Archives: clinical trial

Effect of Food on the Pharmacokinetics of Gliclazide 60 mg Modified Release Tablet in Healthy Caucasian Volunteers

DOI: 10.2478/amma-2018-0022

Objective: To evaluate the food effect on glicazide disposition in clinical trials conducted on healthy Caucasian volunteers who were given a new modified release oral formulation of Gliclazide 60 mg developed by Sun Pharmaceutical Industries, India.
Methods: The studies were designed as open-label, randomized, single-dose, crossover studies that consisted of two periods. During each study, venous blood samples were taken before and after drug administration up to 96 hours. Subsequently, individual plasma profiles were determined and non-compartmental method was employed for the assessment of food effect on the pharmacokinetic profile of gliclazide. The statistical significance of differences for the main pharmacokinetic parameters was evaluated by ANOVA test, for p < 0.05 statistical significance was decided. The relative profiles of absorption of gliclazide were obtained by mathematical deconvolution. All calculations were performed by Phoenix WinNonlin®.
Results: High-fat, high-calorie meal decreased gliclazide exposure. The mean maximum plasma concentration decreased with 14%, while the mean total area under the plasma concentration-time profile registered a 17% decrease. The elimination half-lives under fasted and fed conditions were comparable and the time to maximum plasma concentration was shortened under fed condition. Safety evaluation showed that overall gliclazide was well tolerated under both fasted and fed condition.
Conclusions: The statistical analysis revealed the lack of food effect on the new modified release tablets of Gliclazide 60 mg. However, before stating a definite conclusion regarding the food effect on gliclazide pharmacokinetic profile, additional studies on patients with type 2 diabetes mellitus should be conducted.

Full text: PDF

Specialized Software Engineering in Clinical Trials. GANfort Study

Objective: We aim to develop and implement a personalized software to accomplish data quality management in real time, reducing the chance of error in data collection and a “real time biostatistics” software linked to a collector datasheet.
Material and methods: We used C++ for programming, R for statistics and JavaScript (AJAX) for the interface. This application was deve-loped for phase 3 GANfort study. This is a multicentric study. The results presented are simulated.
Results: The application presented below has a datasheet collection view with three tabs and a general presentation of the study and patient. The first tab collects data from the first visit (study inclusion and initiating the treatment), the second tab is for surveillance visit and the third tab generates real time statistic parameters.
Discussions: Using this type of software many methodological problems concerning data management can be avoided. “Missing data” and “outliers” or writing and typing errors become non-existent; typing constraints issued by datasheets and real time biostatistics eliminate them. The data can be introduced in the same time in different places and the matching data is performed simultaneously.
Conclusions: The time consuming data quality management is automatically solved using the software we proposed. Statistical parameters are calculated in real time. The end of data collection coincides with a final report of the study.

Full text: PDF