An Open label, balanced, randomized, truncated, two treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Pilestop Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) by The ACME Laboratories Ltd., with Daflon 500 Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) of LES Laboratories Servier Industrie in healthy, adult human, subjects under fed 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 and AUC0-72
研究概览
简要总结
STUDY TITLE:
An Open label, balanced, randomized, truncated, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Pilestop Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) by The ACME Laboratories Ltd., with Daflon 500 Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) of LES Laboratories Servier Industrie in healthy, adult, human subjects, under fed conditions.
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Pilestop Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) by The ACME Laboratories Ltd., with Daflon 500 Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) of LES Laboratories Servier Industrie in healthy, adult, human subjects, under fed conditions.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Pilestop Tablet (Diosmin 450 mg + Hesperidin 50 mg film-coated tablet) in healthy, adult, human subjects, under fed condition.
Number of subjects: Twenty-four (24) subjects
Duration of clinical study: 15 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 55.00 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 18-55 years (both inclusive) of age.
- •Body mass index in the range of 18.5 – 30.0 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
- •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.
- •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.
结局指标
主要结局
To evaluate Pharmacokinetics parameters: Cmax and AUC0-72
时间窗: From Day 01 to Day 15
次要结局
- To evaluate Pharmacokinetics parameters: Tmax, λz and t1/2(From Day 01 to Day 15)
研究者
Dr Ankita Das
ICBio Clinical Research Private limited