MedTrace Logo

Dose Modification Requirement for Trelagliptin in Egyptian Population

NCT04374864 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-05-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trelagliptin

Anti diabetic

Sponsors & Collaborators

  • Nermeen Ashoush

    collaborator UNKNOWN

  • Shereen Mowaka

    collaborator UNKNOWN

  • Mariam M. Tadros

    collaborator UNKNOWN

  • British University In Egypt

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-06-01
Completion
2020-07-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374864 on ClinicalTrials.gov