Clinical trial NCT03362398: Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers
Official title: LC-MS/MS Quantitative Determination of Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers' Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 12
Sex: MALE
Minimum age (years): 23
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Type-2 diabetes
* Hospitalized within 1 week

Primary outcomes:
measure: Human plasma concentration of 12 participants will be measured after 1.5 h
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
Study officials:
References: