| Trial ID: | L2936 |
| Source ID: | NCT03895229
|
| Associated Drug: |
Empagliflozin 10 Mg Oral Tablet [Jardiance]
|
| Title: |
The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Pharmacokinetics|Pharmacodynamics
|
| Interventions: |
DRUG: Empagliflozin 10 MG Oral Tablet [Jardiance]
|
| Outcome Measures: |
Primary: 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: 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|Half life( t½) of drug in plasma, Half life of drug measured in Hours(hr), Up to 48 hours
|
| Sponsor/Collaborators: |
Sponsor: Ain Shams University | Collaborators: Drug Research Centre, Cairo, Egypt
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2018-10-01
|
| Completion Date: |
2018-10-26
|
| Results First Posted: |
|
| Last Update Posted: |
2019-04-02
|
| Locations: |
Drug research centre, Cairo, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT03895229
|
