Trials / Completed
CompletedNCT04880993
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions
A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to evaluate the bioequivalence between: * Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and * Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP, USA; after a single-dose in healthy subjects under fasting conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin 10 mg tablets | Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd |
| DRUG | Farxiga® 10 mg tablets | Manufactured by AstraZeneca Pharmaceuticals LP |
Timeline
- Start date
- 2020-12-14
- Primary completion
- 2020-12-24
- Completion
- 2021-02-04
- First posted
- 2021-05-11
- Last updated
- 2021-05-11
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04880993. Inclusion in this directory is not an endorsement.