drugset / Trial / NCT03059056

Pharmacokinetic Evaluation of Empagliflozin

NCT03059056

Phase 1 Completed 6 enrolled British University In Egypt
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2017-02-02
Primary completion
2017-02-02
Completion
2017-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 25 mg Oral

Indications