NCT02637037

A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Detailed description

This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in healthy subjects (males and females of non-childbearing potential)

Conditions

• Bioequivalence
• Fixed Dose Combination Tablets
• Healthy Male and Female Subjects

Interventions

Type	Name	Description
DRUG	dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)	single fixed-combination dose tablets
DRUG	dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)	single fixed-dose combination tablets
DRUG	dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)	single fixed-dose combination tablets
DRUG	dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)	single fixed-dose combination tablets

Timeline

• Start date: 2015-12-21
• Primary completion: 2016-04-07
• Completion: 2016-04-07
• First posted: 2015-12-22
• Last updated: 2018-03-13
• Results posted: 2018-03-13

Locations

1 site across 1 country: United States