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Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions

NCT04881006 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-11

No results posted yet for this study

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

DRUG

Dapagliflozin 10 mg tablets

Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

DRUG

Farxiga® 10 mg tablets

Manufactured by AstraZeneca Pharmaceuticals LP

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2020-12-20
Completion
2021-01-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881006 on ClinicalTrials.gov