At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin Modified Release Film-coated Tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) Versus the Combined Use of Forxiga™ (Dapagliflozin), Film-coated Tablets, 10 mg (Bristol Myers Squibb Company, USA) and Two Glucophage® Long (Metformin), ER Tablets, 500 mg (Merck Santé S.A.S., France), Co-administered to Healthy Volunteers Under Standard Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Xigduo XR, Metformin ER (Glucophage® long), and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg) (Merck Santé S.A.S., France) which are already registered in the Russian Federation.
Study Details
Timeline
Interventions
a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release
co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).