Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers

NCT03362398 | Completed

• 1 other identifier: CDRD-4
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Omarigliptin

ACTIVE COMPARATOR

Drug: Omarigliptin 25 mg

Drug: Omarigliptin 25 mg

Trelagliptin

ACTIVE COMPARATOR

Drug: Trelagliptin 100 mg

Drug: Trelagliptin 100 mg

Interventions

Omarigliptin 25 mg DRUG

Once weekly new anti-diabetic drug approved only in Japan

Also known as: Zafatek tablets

Omarigliptin

Trelagliptin 100 mg DRUG

Once weekly new anti-diabetic drug approved only in Japan

Also known as: Marizev tablets

Trelagliptin

Eligibility Criteria

• Age: 23 Years - 37 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Must be able to swallow tablets

You may not qualify if:

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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine; trelagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Chemistry

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 5, 2017
• Study Start: November 20, 2017
• Primary Completion: November 27, 2017
• Study Completion: November 28, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-11

Locations

EG (1)