An open label, balanced, randomized, two-treatment, twoperiod, two-sequence,single oral dose, crossover, bioequivalence study of Esomeprazole 20 mg & Naproxen 500 mg Delayed Release Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Vimovo 20/500 mg Delayed Release Tablets (EsomeprazoleMagnesium 20 mg + Naproxen 500 mg) of AstraZeneca in healthy, adult, human subjects underfasting condition.

Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

研究概览

暂无简介。

•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 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 blood 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

Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)