Trials / Completed
CompletedNCT03771781
Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Test Formulation With Reference Formulation in Healthy Adult Subjects.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.
Detailed description
A Single-Center,Open-Label,Randomized,Single-Dose,Two-Period,Two-Sequence,Crossover Study to Assess the Bioequivalence of Test Formulation Empagliflozin Tablets with Reference Formulation Jardiance® in Chinese Healthy Adult Subjects under Fasting and Fed Conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empagliflozin Tablets | Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets. |
| DRUG | Empagliflozin Tab 25 MG | Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）. |
Timeline
- Start date
- 2018-04-16
- Primary completion
- 2018-05-25
- Completion
- 2018-05-25
- First posted
- 2018-12-11
- Last updated
- 2019-02-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03771781. Inclusion in this directory is not an endorsement.