An open label, balanced, randomized, two-treatment, twoperiod,two-sequence, single oral dose, crossover,bioequivalence study of Sitagliptin 100 mg & MetforminHydrochloride 1000 mg (extended release) Tablets of SunGlowLifescience Private Ltd., in comparison with Janumet XR 100mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extendedrelease) tablets 100 mg/1,000 mg} of Merck Sharp & DohmeCorp in healthy, adult, human subjects under fasting conditions.

SunGlow Lifescience Private Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

研究概览

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•1. Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
•2. Willing to be available for the entire study period and to comply with protocol requirements.
•3. Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
•4. Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).
•5. Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.

•1. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.
•2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
•3. History of severe infection or major surgery in the past 6 months.
•4. History of Minor surgery or fracture within the past 3 months.
•5. Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.

发起方

SunGlow Lifescience Private Ltd