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Pharmacokinetic Evaluation of Empagliflozin

NCT03059056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • British University In Egypt

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
33 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2017-02-02
Completion
2017-02-02
FDA Drug
Yes

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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 NCT03059056 on ClinicalTrials.gov