Effect of UGT Genetic Variation on Pharmacokinetics of Empagliflozine

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this works is to investigate the effect of genetic polymorphism of snps on human response to treatment with empagliflozine and its correlation with with pharmacokinetic parameters in Egyptian subjects

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams University
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Subjects should be healthy adult volunteers with age between (18-45 years) with normal body weight. Subjects should understand the procedures and are willing to participate and gave their final written consent prior to the commencement of the study procedures. The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests [hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).

Exclusion Criteria:

• 1)Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.

(2) Subjects who have taken any medication less than two weeks of the trials starting date.

(3) Susceptibility to allergic reactions to study drugs. (4) Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.

(5) Gastrointestinal diseases. (6) Renal diseases. (7) Cardiovascular diseases. (8) Pancreatic disease including diabetes. (9) Hepatic diseases. (10) Hematological disease or pulmonary disease (11) Abnormal laboratory values. (12) Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.