The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin

Ain Shams University

Status and phase

Completed

Phase 1

Conditions

Pharmacodynamics

Diabetes Mellitus

Pharmacokinetics

Treatments

Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]

Study type

Interventional

Funder types

Other

Identifiers

NCT03895229

EMP-RES-BES-1018/0011

Details and patient eligibility

About

An Open-label, One way, Two period Comparative study To Determine The effect of Morning Versus Evening administration of Empagliflozin 10mg on Its Pharmacokinetics And Pharmacodynamics in Healthy Adults

Full description

Sixteen(16) healthy subjects will receive a single oral dose of Empagliflozin at the evening(Period I) and after a seven days washout period, the same 16 subjects will receive a single oral dose of Empagliflozin at the morning(Period II).

In both Periods(I and II), blood samples will be collected from each volunteer ethylene diamine tetra-acetic acid(KEDTA) containing tubes prior to drug administration then samples will be obtained at 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours(h) after drug administration.

These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.

Urine samples will be collected over the first 24h after oral administration of the drug with sampling being at the following intervals: 0 to 4h, 4 to 8h, 8-12h, 12 to 24hr.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is at least 18-45 years at screening.
Subject has a Body Mass Index of 18 to 35 kg/m2.
Subject are non smokers or moderate smokers(not more than 5 cigarettes per day)
Subject is willing to participate and give their final written consent prior to the commencement of the study procedures
Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.
Subject has a normal blood pressure and pulse rate, according to the reference normal ranges

Exclusion criteria

Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
Subjects who have taken any medication two weeks preceding of the trial starting date.
Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
Gastrointestinal diseases.
Renal diseases.
Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .
Pancreatic disease including diabetes.
Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases
Hematological disease or pulmonary disease
Abnormal laboratory values.
Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.
Positive HIV test.
History of or current abuse of drugs, alcohol or solvents.
Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extra-hepatic tumors
Autoimmune disorders as Graves disease
(Central nervous system (CNS) disorders