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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01305551
• Date of registration: 25/02/2011
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin Hydrochloride (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
• Date of first enrolment: March 2011
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01305551
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Brazil

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Metformin XR

Drug: Saxagliptin

Drug: Saxagliptin/Metformin XR FDC

Primary Outcome(s)

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. [Time Frame: 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. [Time Frame: 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. [Time Frame: 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. [Time Frame: 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. [Time Frame: 48 hours after dosing]

Secondary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 3 days after dosing]

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 [Time Frame: 3 days after dosing]

Secondary ID(s)

CV181-146

Source(s) of Monetary Support

Please refer to primary and secondary sponsors