British University In Egypt Rövid összefoglaló The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences.
The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study. Részletes leírás The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations.
Fasting of all volunteers will eliminate the possible interaction diabetes and high pulse rate food or caffeine consumption.
The pharmacokinetic parameters of Trelagliptin will be studied in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki October and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided attached and signed by the six volunteers in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt.
The good health of the human subjects was confirmed by a complete medical history and physical examination.
Samples from six, healthy, adult, male, smoking, Egyptian volunteers age: years, average weight: Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect.
The study will be conducted as per FDA guidelines. The development of such correlations between trelagliptin concentrations and its pharmacologic responses will enable clinicians to apply pharmacokinetic principles to actual patient situations.
The evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination. Átfogó állapot.