Pharmacokinetic Evaluation of Empagliflozin

Diabetes Mellitus Clinical Trial

Official title:

Pharmacokinetic Evaluation of Empagliflozin in Healthy Egyptian Volunteers Using LC-MS/MS: Compared With Other Ethnic Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059056
• Other study ID #: YIRG-2016-01
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2017
• Last updated: February 16, 2017
• Start date: February 2, 2017
• Est. completion date: February 2, 2017

Study information

• Verified date: February 2017
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Project PI (Principal Investigator): Dr Bassam Mahfouz Ayoub, Ph.D., Lecturer of Pharmaceutical Chemistry, The British University in Egypt.

Study Design The proposed study will consider the pharmacokinetic evaluation of empagliflozin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, randomized, one treatment, one period, single dose pharmacokinetic study.

Description:

Study Design The proposed study will consider the pharmacokinetic evaluation of empagliflozin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, randomized, one treatment, one period, single dose pharmacokinetic study. The main pharmacokinetic parameters which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf, will be estimated. Fasting of all volunteers will eliminate the possible interaction from food or caffeine consumption. The pharmacokinetic parameters of empagliflozin will be studied 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 six 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 six, healthy, adult, male, smoking, Egyptian volunteers (age: 22-33 years, Average weight: 77.8 kg, Average BMI: 29.2) will be collected at 0, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 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 Jardiance® tablet nominally containing 25 mg of empagliflozin. The blood samples (3 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, one mL of the plasma will be separated and spiked with 100 µL (equivalent to 100 ng) of internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. The main pharmacokinetic parameters of the study which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf will be estimated, using a validated excel software. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect. The study will be conducted as per FDA guidelines. The development of such correlations between empagliflozin concentrations and its pharmacologic responses will enable clinicians to apply pharmacokinetic principles to actual patient situations. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 33 Years

Eligibility

Inclusion Criteria:

• The good health of the human subjects was confirmed by a complete medical history and physical examination.

Exclusion Criteria:

• Chronic disease

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Empagliflozin 25mg
Samples from six, healthy, adult, male, smoking, Egyptian volunteers (age: 22-33 years, Average weight: 77.8 kg, Average BMI: 29.2) will be collected at 0, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 h after administration of Empagliflozin 25 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	The peak plasma concentration of a drug after administration	12 Hours
Primary	Tmax	Time to reach Cmax.	12 Hours
Primary	Elimination half life	The time required for the concentration of the drug to reach half of its original value.	12 Hours
Primary	Elimination rate constant	The rate at which a drug is removed from the body.	12 Hours
Primary	Area under the curve	The integral of the concentration-time curve	12 Hours