Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers
Status:
Completed
Trial end date:
2017-11-28
Target enrollment:
Participant gender:
Summary
The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin &
Trelagliptin after administration to twelve Egyptian volunteers. The main aim of the study is
to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drugs in
the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the
study is open labeled, randomized, one treatment, one period, single dose study. The
concentration of the drugs after 1.5 h will be determined in healthy human subjects according
to the ethical regulations of World Medical Association Declaration of Helsinki (October
1996) and the International Conference of Harmonisation Tripartite Guideline for Good
Clinical Practice. Written informed consent was provided (attached and signed by the twelve
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 twelve, healthy, adult, male,
smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4)
will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be
analyzed by LC-MS/MS study (developed & validated) after single oral dose administration of
one Marizev® tablet nominally containing 25 mg of Omarigliptin (first arm as 6 volunteers) or
one Zafatek® tablet nominally containing 100 mg of Trelagliptin (second arm as 6 volunteers).
The blood samples (0.5 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100
µL of the plasma will be separated and spiked with the internal standard working solution and
then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level
will be determined for all volunteers at different time intervals to monitor any hypoglycemic
effect to ensure their safety all over the study. The study will be conducted as per FDA
guidelines & 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.