Diabetes Mellitus, Pharmacodynamics, Pharmacokinetics
Conditions
Keywords
Diabetes, Empagliflozin, Circadian rythm
Brief summary
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
Detailed 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.
Interventions
Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus
Sponsors
Drug Research Centre, Cairo, Egypt
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single group of 16 subjects will receive a single oral dose of Empagliflozin 10 MG Oral Tablet \[Jardiance\] at the morning(Period I) and the same group will receive the same dose of the same drug at the evening(Period II) after a seven days washout period
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum drug concentration in plasma (Cmax) | 0 up to 4 hours | Maximum drug concentration in plasma measured in (ng/ml) |
| Area under the plasma concentration-time curve from time 0 to 48 hours(h) (AUC0→48h) | From first sampling interval up to 48 hours | Area under the plasma concentration-time curve from time 0 to time(t) measured in(ng.h/ml) |
| Time to Maximum drug concentration in plasma (tmax) | 0 up to 4 hours | Time corresponding to maximum drug concentration in plasma measured in Hours(h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Urinary Glucose Excreted over the first 24 hours (Cumulative UGE) | From 0 up to 24 hours | The Cumulative amount of Glucose excreted in Urine over the first 24 hours after drug administration measured in Milligrams (mg) |
| Half life( t½) of drug in plasma | Up to 48 hours | Half life of drug measured in Hours(hr) |
Countries
Egypt
Outcome results
None listed