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
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|
|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|
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
- Cmax [ Time Frame: 12 Hours ]The peak plasma concentration of a drug after administration
- Tmax [ Time Frame: 12 Hours ]Time to reach Cmax.
- Elimination half life [ Time Frame: 12 Hours ]The time required for the concentration of the drug to reach half of its original value.
- Elimination rate constant [ Time Frame: 12 Hours ]The rate at which a drug is removed from the body.
- Area under the curve [ Time Frame: 12 Hours ]The integral of the concentration-time curve