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

NCT03895229 | Completed Phase 1

• 1 other identifier: EMP-RES-BES-1018/0011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus; Pharmacokinetics; Pharmacodynamics

Keywords

Diabetes; Empagliflozin; Circadian rythm

Outcome Measures

Primary Outcomes (3)

• Maximum drug concentration in plasma (Cmax)

  Maximum drug concentration in plasma measured in (ng/ml)

  0 up to 4 hours

• 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

• 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 Outcomes (2)

• Cumulative Urinary Glucose Excreted over the first 24 hours (Cumulative UGE)

  From 0 up to 24 hours

• Half life( t½) of drug in plasma

  Up to 48 hours

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Subjects will receive a single oral dose of Empagliflozin 10 MG Oral Tablet \[Jardiance\]

Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]

Interventions

Empagliflozin 10 MG Oral Tablet [Jardiance] DRUG

Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus

Also known as: Jardiance (Boehringer Ingelheim and Eli Lilly)

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead
• Drug Research Centre, Cairo, Egypt: collaborator

Study Sites (1)

Drug research centre

Cairo, Egypt

Location

Related Publications (1)

• ElDash RM, Raslan MA, Shaheen SM, Sabri NA. The effect of morning versus evening administration of empagliflozin on its pharmacokinetics and pharmacodynamics characteristics in healthy adults: a two-way crossover, non-randomised trial. F1000Res. 2021 Apr 26;10:321. doi: 10.12688/f1000research.51114.1. eCollection 2021.

  PMID: 34123370 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin; Tablets

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rana M Ali, MD student

  Ainshams University

  PRINCIPAL INVESTIGATOR

• Nagwa A Sabry, phD

  Ainshams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: October 1, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 26, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-04

Locations

EG (1)