Dose Modification Requirement for Trelagliptin in Egyptian Population

Summary

The proposed study will consider the pharmacokinetic evaluation of Trelagliptin 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, one treatment, one period, single dose pharmacokinetic study.

Timeline

Start

2020-03-01

Primary completion

2020-06-01

Completion

2020-07-01

Drugs

Indications