Pharmacokinetic Evaluation of Empagliflozin
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Empagliflozin 25mg
Intervention type(s): Drug
Intervention description(s): 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
Other intervention name(s): Jardiance
Intervention MeSH terms: Empagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science