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Label indication XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. FDA label
Also known as Xigduo XR
Xigduo · 1 trial · 1 indication
The drugs are considered bioequivalent if the 90% confidence intervals for the Test : Reference products geometric least squares mean ratios of AUC, Cmax и Cmax/AUC parameters are in the range of 80% - 125%.
Adverse events data for Dapagliflozin + Metformin, modified-release film-coated tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) and for co-administered Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg, (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), XR tablets, 500 mg/2 tablets (Merck Santé S.A.S, France)
| Arm | Type | Description |
|---|---|---|
| T/R | EXPERIMENTAL | Test product (T): 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. Volunteers enrolled to group 1, on the first study period will take the study test product (Т), and on the second study period after wash out period of 7 days the volunteers will be given the Reference product (R) |
| R/T | EXPERIMENTAL | Reference product (R): 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). Volunteers from group 2 will be administered with the study drug in reverse order. It means that group 1 will take the study products in sequence T-R and group 2 in the sequence R-T. |
| Name | Type | Description |
|---|---|---|
| Xigduo XR | DRUG | 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 |
| Metformin ER (Glucophage® long) | DRUG | 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). |
| Dapagliflozin (Forxiga) | DRUG | 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). |
Inclusion Criteria: 1. The volunteer is able to understand the requirements of the study, to sign the informed consent form, and agrees with all the restrictions imposed in the course of the study; 2. Male and female subjects aged 18-45, inclusive; 3. Caucasian race; 4. Body-mass index (BMI) within...
Xigduo is used for the treatment of type 2 diabetes mellitus. It combines dapagliflozin and metformin in a single fixed-dose tablet. Xigduo is developed by AstraZeneca PLC under the ticker AZN. The product is intended for adults with type 2 diabetes as part of a metabolic treatment approach.
Xigduo is made by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the developer of the fixed-dose combination of dapagliflozin and metformin. The company holds the asset within its metabolic therapeutic area.
Xigduo is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a randomized, controlled, open-label crossover pharmacokinetic and bioequivalence study conducted in healthy volunteers.
Xigduo has been studied in one completed Phase 1 trial, NCT02722239. This was an open-label, randomized, crossover study comparing the pharmacokinetics and bioequivalence of dapagliflozin plus metformin 10 mg plus 1000 mg versus co-administered Forxiga 10 mg and two Glucophage Long ER 500 mg tablets in healthy volunteers under fed conditions. The trial enrolled 40 participants in Russia.
Yes, Xigduo XR is an alternative name for Xigduo. Both names refer to the same fixed-dose combination product containing dapagliflozin and metformin, developed by AstraZeneca PLC for type 2 diabetes mellitus.