An Open label, balanced, randomized, two-treatment, twoperiod, two-sequence, single dose, crossover, oral,bioequivalence study of Esomeprazole 40 mg MUPS tablets ofSunGlow Lifescience Private Ltd with Nexium mups 40 mggastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions. - NI

SunGlow Lifescience Private Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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 18.5 – 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. Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for
•2. Any medical or surgical condition, which might significantly interfere with the functioning
•of the gastrointestinal tract or blood–forming organs.
•3. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime
•in the past.
•4. History of severe infection or major surgery in the past 6 months.
•5. History of Minor surgery or fracture within the past 3 months.

发起方

SunGlow Lifescience Private Ltd