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

NCT ID: NCT03895229

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2018-10-26

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.

Conditions

Diabetes Mellitus; Pharmacokinetics; Pharmacodynamics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Arm

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

Group Type: EXPERIMENTAL

Empagliflozin 10 MG Oral Tablet [Jardiance]

Intervention Type: DRUG

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

Interventions

Empagliflozin 10 MG Oral Tablet [Jardiance]

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

Intervention Type: DRUG

Other Intervention Names

Jardiance (Boehringer Ingelheim and Eli Lilly)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Drug Research Centre, Cairo, Egypt

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Raslan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rana M Ali, MD student

Role: PRINCIPAL_INVESTIGATOR

Ainshams University

Nagwa A Sabry, phD

Role: STUDY_DIRECTOR

Ainshams University

Locations

Drug research centre

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 34123370 (View on PubMed)

Other Identifiers

EMP-RES-BES-1018/0011

Identifier Type: -

Identifier Source: org_study_id