Overview

Effect of Genetic Polymorphisms of UGT on the PKs of Indapamide in Egyptians

Status:
Not yet recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this works is to investigate the effect of genetic variation of UGT2B7 on human response to treatment with indapamide and its correlation with pharmacokinetic parameters in Egyptian subjects.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ain Shams University
Treatments:
Indapamide
Criteria
Inclusion Criteria:

- Subjects should be healthy adult volunteers with age between (18-45) with normal body
weight.

- 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:

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

- Subjects who have taken any medication less than two weeks of the trials starting date

- Susceptibility to allergic reaction to study drugs

- Any prior surgery of the gastrointestinal tract that may interfere with drug
absorption

- Gastrointestinal diseases

- Renal diseases

- Pancreatic disease including diabetes

- Hepatic diseases

- Hematological diseases or pulmonary diseases

- Abnormal laboratory values

- Subject 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.