Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04880993
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2021-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions
Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: