Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.
Detailed description
Primary purpose: To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR FDC tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.
Interventions
DRUGSaxagliptin
Tablet, Oral, 5 mg, once on Day 1 only
DRUGMetformin XR
Tablet, Oral, 500 mg, once on Day 1 only
Tablet, Oral, 5/500 mg, once on Day 1 only
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women * Women of childbearing potential (WOCBP) who are using acceptable method of contraception * Women who are not nursing
Exclusion criteria
* History of Gastrointestinal (GI) disease * Any GI surgery that could impact study drug absorption * History of allergy to drug class or related compounds * History of allergy to metformin or other similar acting agents. * History of any significant drug allergy. * Estimated creatinine clearance (ClCr) \< 80 mL/min using Cockcroft-Gault formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of BE on single-dose pharmacokinetic parameters time of maximum observed concentration (Tmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. | 48 hours after dosing | — |
| Evidence of BE on single-dose pharmacokinetic parameters area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. | 48 hours after dosing | — |
| Evidence of BE on single-dose pharmacokinetic parameters half-life (T-HALF) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. | 48 hours after dosing | — |
| Evidence of BE on single-dose pharmacokinetic parameters maximum observed concentration (Cmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. | 48 hours after dosing | — |
| Evidence of BE on single-dose pharmacokinetic parameters (AUC(0-T) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. | 48 hours after dosing | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin, from 5 mg Saxagliptin/500 mg Metformin XR FDC tablet & from 5 mg Onglyza administered together with 500 mg Glifage® XR in single-dose fed & fasted state pharmacokinetics in healthy subjects | 3 days after dosing | Amount of the active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin (BMS-510849), from the 5 mg Saxagliptin/500 mg Metformin XR FDC tablet and from 5 mg Onglyza™ administered together with 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) in single-dose fed and fasted state pharmacokinetics in healthy subjects |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 days after dosing | — |
Countries
Brazil
Outcome results
None listed