NCT04881006

Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions

A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fed 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 fed conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.

Conditions

• Healthy Subjects

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: 2020-12-10
• Primary completion: 2020-12-20
• Completion: 2021-01-15
• First posted: 2021-05-11
• Last updated: 2021-05-11

Locations

1 site across 1 country: Canada