An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., in comparison with Diamicron 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., in comparison with Diamicronâ 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition.
Primary objective:
To compare the rate and extent of absorption of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., with that of Diamicronâ 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Gliclazide 60 mg MR tablets in healthy, adult, human subjects under fasting condition.
Number of subjects: Twenty eight (28)
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
- •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).
排除标准
- •â€¢ Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
- •â€¢ History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •â€¢ History of severe infection or major surgery in the past 6 months.
- •â€¢ 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- Day 14
次要结局
- Tmax , AUC_%Extrap_obs, λz and t1/2(Day 01- Day 14)