Overview

Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions

Status:
Completed
Trial end date:
2021-01-15
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin