Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.

Exclusion criteria

• . Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any of its metabolites/derivatives or related drugs or excipients.
• . Have a positive test result for HBs Ag or HCV Ab or HIV antibodies (types 1 and 2) or VDRL.
• . The study drug is contraindicated for medical reasons for the subject as per protocol section 3.7.
• . Have any history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, neurological or psychiatric disease or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute confusional states) as judged by the PI considering the pharmacology of IP(s).
• . Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• . Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days prior to dosing of period 1.
• . Have history or presence of cancer.
• . Have a history or evidence of drug abuse or alcohol abuse.