An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Metformin prolonged release tablets 1000 mg of Pinnacle Life Science Pvt. Ltd., in comparison with Glucophage®1000 mg XR tablets (Metformin Hydrochloride prolonged release tablets) of Merck Sante S.A.S in healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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 oral dose, crossover, bioequivalence study of Metformin prolonged release tablets 1000 mg of Pinnacle Life Science Pvt. Ltd., in comparison with Glucophage®1000 mg XR tablets (Metformin Hydrochloride prolonged release tablets) of Merck Sante S.A.S in healthy, adult, human subjects under fasting conditions.
Objective:
Primary objective:
To compare the rate and extent of absorption of Metformin prolonged release tablets 1000 mg of Pinnacle Life Science Pvt. Ltd., with that of Glucophage®1000 mg XR tablets (Metformin Hydrochloride prolonged release tablets) of Merck Sante S.A.S in healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Metformin prolonged release tablets 1000 mg in healthy adult human subjects under fasting conditions.
Number of subjects: 24
Study duration: 11 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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).
排除标准
- •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
Cmax, AUC0-t and AUC0-∞
时间窗: Day 01 to 11
次要结局
- Tmax , AUC_%Extrap_obs, λz and t1/2(Day 01 to 11)