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Trial record 25 of 186 for:    BI10773

Pharmacokinetic Evaluation of Empagliflozin

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ClinicalTrials.gov Identifier: NCT03059056
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Bassam Mahfouz Ayoub, British University In Egypt

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Empagliflozin 25mg Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic Evaluation of Empagliflozin in Healthy Egyptian Volunteers Using LC-MS/MS: Compared With Other Ethnic Populations
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pharmacokinetic evaluation
Empagliflozin 25 mg
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
Other Name: Jardiance




Primary Outcome Measures :
  1. Cmax [ Time Frame: 12 Hours ]
    The peak plasma concentration of a drug after administration

  2. Tmax [ Time Frame: 12 Hours ]
    Time to reach Cmax.

  3. Elimination half life [ Time Frame: 12 Hours ]
    The time required for the concentration of the drug to reach half of its original value.

  4. Elimination rate constant [ Time Frame: 12 Hours ]
    The rate at which a drug is removed from the body.

  5. Area under the curve [ Time Frame: 12 Hours ]
    The integral of the concentration-time curve



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic disease

Responsible Party: Bassam Mahfouz Ayoub, Lecturer of Pharmaceutical Chemistry, British University In Egypt
ClinicalTrials.gov Identifier: NCT03059056     History of Changes
Other Study ID Numbers: YIRG-2016-01
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication of data in a scientific journal

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs