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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895229
• Other study ID #: EMP-RES-BES-1018/0011
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: October 26, 2018

Study information

• Verified date: April 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 26, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pharmacodynamics
• Pharmacokinetics

Intervention

Drug:
• Empagliflozin 10 MG Oral Tablet [Jardiance]
Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus

Locations

Country	Name	City	State
Egypt	Drug research centre	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Drug Research Centre, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum drug concentration in plasma (Cmax)	Maximum drug concentration in plasma measured in (ng/ml)	0 up to 4 hours
Primary	Area under the plasma concentration-time curve from time 0 to 48 hours(h) (AUC0?48h)	Area under the plasma concentration-time curve from time 0 to time(t) measured in(ng.h/ml)	From first sampling interval up to 48 hours
Primary	Time to Maximum drug concentration in plasma (tmax)	Time corresponding to maximum drug concentration in plasma measured in Hours(h)	0 up to 4 hours
Secondary	Cumulative Urinary Glucose Excreted over the first 24 hours (Cumulative UGE)	The Cumulative amount of Glucose excreted in Urine over the first 24 hours after drug administration measured in Milligrams (mg)	From 0 up to 24 hours
Secondary	Half life( t½) of drug in plasma	Half life of drug measured in Hours(hr)	Up to 48 hours