Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers

LC-MS/MS Quantitative Determination of Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers' Plasma

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Omarigliptin 25 mg; Drug: Trelagliptin 100 mg

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • The British University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy volunteers
• Must be able to swallow tablets

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omarigliptin; Drug: Omarigliptin 25 mg	Drug: Omarigliptin 25 mg; Once weekly new anti-diabetic drug approved only in Japan; Other Names: Zafatek tablets
Active Comparator: Trelagliptin; Drug: Trelagliptin 100 mg	Drug: Trelagliptin 100 mg; Once weekly new anti-diabetic drug approved only in Japan; Other Names: Marizev tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human plasma concentration of 12 participants will be measured after 1.5 h	The main purpose of this outcome is to check the suitability of the developed LC-MS/MS method for determination of the drugs in human plasma	2 weeks

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): November 27, 2017
• Study Completion (Actual): November 28, 2017

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CDRD-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No