Introduction and Rationale
Diabetic patients have major risk of cardiovascular disease leading cause of morbidity and mortality. The aim of this study is the importance of choosing drugs that do not increase cardiovascular risk and reduce the risk of cardiovascular events. The US FDA and has recommended its Guidance for Industry for drug developers in 2008 that new drugs for type 2 diabetes undergo clinical trials should fulfill cardiovascular safety in addition to glycemic benefit and rule out potentially harmful drug interactions. The European Medicines Agency recommended same. Cautious selection of the drug therapy, specifically cardiovascular safety with controlled diabetes. Patients with diabetes often showing atherosclerosis and are at …show more content…
Study …show more content…
This was a Phase III, Multi-center, randomized, bioequivalence (BE) study of the fixed dose combination (FDC) of saxagliptin/metformin extended release (XR) relative to co-administration of the individual drugs components in 2 cohorts of healthy male subjects under fed conditions.. The 2 cohorts were independent of each other with respect to treatment and results. Clinical Study Report Synopsis Drug Substance Saxagliptin/Metformin Study Code XXXXXXXXXXXXX. Healthy males aged ≥18 years and ≤50 years. Healthy males (2 cohorts of 750 subjects each) were randomized to get treatment with the investigational product (IP.) Investigational product and comparators: dosage, mode of administration, The IPs was divided into 2 cohorts as follows: Cohort 1
• Treatment A= a single oral dose of a 5 mg saxagliptin tablet and 500 mg metformin XR (Glucophage XR) tablet same time.
• Treatment B=Single FDC tablet containing of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR™1 ). Cohort 2 • Treatment C= a single oral dose of a 5 mg saxagliptin tablet and 1000 mg metformin XR (Glucophage XR) tablets same
Diabetic patients have major risk of cardiovascular disease leading cause of morbidity and mortality. The aim of this study is the importance of choosing drugs that do not increase cardiovascular risk and reduce the risk of cardiovascular events. The US FDA and has recommended its Guidance for Industry for drug developers in 2008 that new drugs for type 2 diabetes undergo clinical trials should fulfill cardiovascular safety in addition to glycemic benefit and rule out potentially harmful drug interactions. The European Medicines Agency recommended same. Cautious selection of the drug therapy, specifically cardiovascular safety with controlled diabetes. Patients with diabetes often showing atherosclerosis and are at …show more content…
Study …show more content…
This was a Phase III, Multi-center, randomized, bioequivalence (BE) study of the fixed dose combination (FDC) of saxagliptin/metformin extended release (XR) relative to co-administration of the individual drugs components in 2 cohorts of healthy male subjects under fed conditions.. The 2 cohorts were independent of each other with respect to treatment and results. Clinical Study Report Synopsis Drug Substance Saxagliptin/Metformin Study Code XXXXXXXXXXXXX. Healthy males aged ≥18 years and ≤50 years. Healthy males (2 cohorts of 750 subjects each) were randomized to get treatment with the investigational product (IP.) Investigational product and comparators: dosage, mode of administration, The IPs was divided into 2 cohorts as follows: Cohort 1
• Treatment A= a single oral dose of a 5 mg saxagliptin tablet and 500 mg metformin XR (Glucophage XR) tablet same time.
• Treatment B=Single FDC tablet containing of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR™1 ). Cohort 2 • Treatment C= a single oral dose of a 5 mg saxagliptin tablet and 1000 mg metformin XR (Glucophage XR) tablets same