Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is a combination product containing dapagliflozin and metformin, intended to improve glycemic control in adults with this condition. As of the latest data, Xigduo is in Phase 1 clinical development.
Xigduo is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the pharmacokinetics and bioequivalence of this combination product for the treatment of Type 2 Diabetes Mellitus.
Xigduo is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing development program includes a completed Phase 1 study that assessed the bioequivalence of the combination product in healthy volunteers.
Xigduo has one completed Phase 1 clinical trial registered under NCT02722239. This open-label, randomized, crossover study evaluated the comparative pharmacokinetics and bioequivalence of dapagliflozin plus metformin 10 mg + 1000 mg versus the combined use of Forxiga and Glucophage Long ER tablets in healthy volunteers under fed conditions.
Xigduo is a fixed-dose combination of dapagliflozin and metformin. The Phase 1 trial compared the combination tablet to the separate administration of Forxiga (dapagliflozin) and Glucophage Long ER (metformin) to assess bioequivalence. This suggests Xigduo is designed to provide the same therapeutic effect as the individual components taken together.