| Trial ID: | L4003 |
| Source ID: | NCT03771781
|
| Associated Drug: |
Empagliflozin Tablets
|
| Title: |
Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Empagliflozin Tablets|DRUG: Empagliflozin Tab 25 MG
|
| Outcome Measures: |
Primary: Peak Plasma Concentration (Cmax), Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data., 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours | Secondary: Area under the plasma concentration versus time curves (AUC), Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration., 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
|
| Sponsor/Collaborators: |
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-04-16
|
| Completion Date: |
2018-05-25
|
| Results First Posted: |
|
| Last Update Posted: |
2019-02-21
|
| Locations: |
The Third Hospital of Changsha, Changsha, Hunan, 410000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03771781
|
