Diabetes MellitusPhase 1NCT03895229
The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin
A Phase 1 study testing Empagliflozin 10 MG Oral Tablet [Jardiance] in people with Diabetes Mellitus and Pharmacokinetics, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Pharmacokinetics, Pharmacodynamics
- What is being tested?
- Empagliflozin 10 MG Oral Tablet [Jardiance]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 26 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Empagliflozin 10 MG Oral Tablet [Jardiance]
- Keywords
- Diabetes, Empagliflozin, Circadian rythm
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MG Oral Tablet [Jardiance]Drug
Also called Jardiance (Boehringer Ingelheim and Eli Lilly)
Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Subjects will receive a single oral dose of Empagliflozin 10 MG Oral Tablet [Jardiance] Receives: Drug: Empagliflozin 10 MG Oral Tablet [Jardiance] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration in plasma (Cmax)
Maximum drug concentration in plasma measured in (ng/ml)
Measured: 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)
Measured: 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)
Measured: 0 up to 4 hours
Secondary outcomes (2)
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)
Measured: From 0 up to 24 hours
Half life( t½) of drug in plasma
Half life of drug measured in Hours(hr)
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Oct 2018
- Primary completion19 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Research Centre, Cairo, Egypt
- Responsible party
- Principal investigator, Mohamed Raslan, Ain Shams University
- Investigators
- Rana M Ali, MD student, Principal investigator, Ainshams UniversityNagwa A Sabry, phD, Study director, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895229
- Sponsor's protocol ID
- EMP-RES-BES-1018/0011
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34123370
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin
- ClinicalTrials.gov ID
- NCT03895229
- Acronym / sponsor ID
- EMP-RES-BES-1018/0011
- Conditions
- Diabetes Mellitus, Pharmacokinetics, Pharmacodynamics
- Keywords
- Diabetes, Empagliflozin, Circadian rythm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Drug Research Centre, Cairo, Egypt
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]Subjects will receive a single oral dose of Empagliflozin 10 MG Oral Tablet [Jardiance] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MG Oral Tablet [Jardiance]Also: Jardiance (Boehringer Ingelheim and Eli Lilly)Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus | Drug | Experimental Arm |
Primary outcome
Maximum drug concentration in plasma (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 0 up to 4 hours
Time corresponding to maximum drug concentration in plasma measured in Hours(h)
2 secondary outcomes
Cumulative Urinary Glucose Excreted over the first 24 hours (Cumulative UGE)
Time frame: From 0 up to 24 hours
Half life( t½) of drug in plasma
Time frame: Up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 34123370ElDash 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana M Ali, MD student principal investigator
Ainshams University
Nagwa A Sabry, phD study director
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Empagliflozin 10 MG Oral Tablet [Jardiance] in people with Diabetes Mellitus and Pharmacokinetics, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum drug concentration in plasma (Cmax) (time frame: 0 up to 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.