Pharmacokinetic Evaluation of Empagliflozin

Sponsor
British University In Egypt
Study ID
NCT03059056
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
MALE
Age
22 Years - 33 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin 25mg — DRUG
    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

Study Details

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.

Key Dates

Start date
Feb 2, 2017
Status verified
Feb 2017
Primary completion
Feb 2, 2017
Completion
Feb 2, 2017

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: pharmacokinetic evaluation
    Empagliflozin 25 mg

Primary Outcome Measure

Cmax [ Time Frame: 12 Hours ]

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