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Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362398
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Bassam Mahfouz Ayoub, British University In Egypt

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Omarigliptin 25 mg Drug: Trelagliptin 100 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: LC-MS/MS Quantitative Determination of Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers' Plasma
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 28, 2017

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 Name: Zafatek tablets

Active Comparator: Trelagliptin
Drug: Trelagliptin 100 mg
Drug: Trelagliptin 100 mg
Once weekly new anti-diabetic drug approved only in Japan
Other Name: Marizev tablets




Primary Outcome Measures :
  1. Human plasma concentration of 12 participants will be measured after 1.5 h [ Time Frame: 2 weeks ]
    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



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Ages Eligible for Study:   23 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Must be able to swallow tablets

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362398


Locations
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Egypt
The British University in Egypt
Cairo, Egypt
Sponsors and Collaborators
British University In Egypt
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Responsible Party: Bassam Mahfouz Ayoub, Lecturer of Chemistry, British University In Egypt
ClinicalTrials.gov Identifier: NCT03362398    
Other Study ID Numbers: CDRD-4
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases