Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
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|ClinicalTrials.gov Identifier: NCT03771781|
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Empagliflozin Tablets Drug: Empagliflozin Tab 25 MG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Test Formulation Empagliflozin Tablets 25 mg With Reference Formulation JARDIANCE® 25 mg in Healthy Adult Subjects.|
|Actual Study Start Date :||April 16, 2018|
|Actual Primary Completion Date :||May 25, 2018|
|Actual Study Completion Date :||May 25, 2018|
The test formulation is manufactured by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.During the study session,subjects will be administered a single does of Empagliflozin Tablets 25mg after fasting and fed conditions.
Drug: Empagliflozin Tablets
Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.
Empagliflozin Tab 25 MG
The reference formulation is manufactured by Boehringer Ingelheim International GmbH.During the study session,subjects will be administered a single does of Empagliflozin Tab 25 MG after fasting and fed conditions.
Drug: Empagliflozin Tab 25 MG
Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.
- Peak Plasma Concentration (Cmax) [ Time Frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours ]Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
- Area under the plasma concentration versus time curves (AUC) [ Time Frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours ]Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771781
|The Third Hospital of Changsha|
|Changsha, Hunan, China, 410000|