BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01305551
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Healthy men and women
- Women of childbearing potential (WOCBP) who are using acceptable method of contraception
- Women who are not nursing
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment A-Saxagliptin+Metformin XR Metformin XR 5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fasted state. Treatment B-Saxagliptin/Metformin XR FDC Saxagliptin/Metformin XR FDC 5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fasted state. Treatment C-Saxagliptin+Metformin XR Metformin XR 5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fed state. Treatment D-Saxagliptin/Metformin XR FDC Saxagliptin/Metformin XR FDC 5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fed state. Treatment A-Saxagliptin+Metformin XR Saxagliptin 5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fasted state. Treatment C-Saxagliptin+Metformin XR Saxagliptin 5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fed state.
- Primary Outcome Measures
Name Time Method 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 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 (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))
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Local Institution
🇧🇷Campinas, Sao Paulo, Brazil