Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fast Condition

Exclusion Criteria

• •Hypersensitivity to Empagliflozin and Metformin or related class of drugs or any of its excipients or heparin.
• •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
• •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
• •Presence of alcoholism or drug abuse.
• •History or presence of asthma, urticaria or other significant allergic reactions.
• •History or presence of significant gastric and/or duodenal ulceration.
• •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• •History or presence of cancer or basal or squamous cell carcinoma.
• •Difficulty with donating blood.
• •Difficulty in swallowing solids dosage form like tablets or capsules.
• •Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
• •Major illness within past 3 months.
• •Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
• •Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.
• •Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.
• •Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
• •History or presence of significant easy bruising or bleeding.
• •History or presence of significant recent trauma.
• •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
• •History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
• •History of Diabetic pre-coma.
• •History of acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
• •History of disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
• •History of Hepatic impairment or acute alcohol intoxication.
• •Female subjects who are currently breast feeding.