An Open label, balanced, randomized, two-treatment, twoperiod, two-sequence, single dose, crossover, oral, bioequivalence study of Esomeprazole 40 mg MUPS tablets of SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
STUDY TITLE:
An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral, bioequivalence study of Esomeprazole 40 mg MUPS tablets of
SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Esomeprazole 40 mg MUPS tablets of SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Esomeprazole 40 mg MUPS tablets in healthy, adult, human subjects under fasting condition.
Number of subjects: Twenty-four (24) subjects
Duration of clinical study: 09 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study.
- •Willing to be available for the entire study period and to comply with protocol requirements.
- •Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- •Body mass index in the range of 18.5 – 30 kg/m2 (both inclusive).
- •Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.
排除标准
- •Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
- •Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
- •History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •History of severe infection or major surgery in the past 6 months.
- •History of Minor surgery or fracture within the past 3 months.
结局指标
主要结局
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
时间窗: From Day 01 to Day 09
次要结局
- To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2(From Day 01 to Day 09)
研究者
Dr Ankita Das
ICBio Clinical Research Private limited