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Clinical trial

A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions

NCT03216278 is registered in ClinicalTrials.gov with AstraZeneca as lead sponsor.

NCT NCT03216278
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Registry record

As filed in ClinicalTrials.gov.

Title
A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions
Lead sponsor
AstraZeneca
Phase
Phase 1
Overall status
Completed
Start date
September 26, 2017
Completion date
May 22, 2018
Enrollment
284 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy subjects in fasted and fed state