Bioequivalence of Diabetes Drug Combinations in Healthy Volunteers
Research type
Research Study
Full title
A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed- and Fasted State Bioequivalence of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects
IRAS ID
225028
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-000507-25
Duration of Study in the UK
0 years, 6 months, 3 days
Research summary
This is a randomised, single-dose, open-label, single-centre, 3-period, 3-treatment, crossover clinical trial and the main objective is to assess the bioequivalence of different fixed-dose combinations relative to the individual components. Bioequivalence involves assessment of pharmacokinetic drug profiles, referring to how study medications are absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) compared to similar study medications (i.e. combined vs separate). The study will also see how safe the drug is after single doses were taken.
The compounds to be studied include saxagliptin, dapagliflozin and metformin, which are approved anti-diabetes medicationThe 2.5mg saxagliptin/5 mg dapagliflozin and 1000 mg metformin triple combination tablets will be administered to humans in a study in the US before this study begins. This study will be the first administration of the triple combination tablet with the 850 mg metformin dose. The individual reference drugs are marketed for use in humans and the duo-combination tablets (both strengths) are marketed for use in the US. Different fixed-dose combinations of the compounds are being developed for patient convenience and to improve patient compliance. Diabetes mellitus is a chronic condition that affects millions of people worldwide and is characterized by elevated glucose levels. Significant unmet need in treatment of this disease still exists, as many patients remain inadequately controlled on their current glucose lowering regimen. The study medication will be taken orally in the form of tablets to be taken with water. Taking only 1 tablet is more convenient and patients are less likely to miss doses.
The study will be performed under fasted and fed conditions in healthy participants. The study comprises a screening visit, three treatment periods and a final follow-up visit within 5 to 7 days after the last administration of study medication. Participants, in each of the three study groups (cohorts), will be randomized to 1 of 6 treatment sequences. Each treatment sequence will be comprised of the same 3 treatment periods in 6 different possible orders and 7 participants per cohort will undergo each of the 6 sequences. Study medication will be administered in either a fasted or fed state (after food or without having eaten) according to the assigned treatment.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0107
Date of REC Opinion
17 May 2017
REC opinion
Further Information Favourable Opinion