An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of Vonoprazan 20 mg Tablets by Laboratorios Leti, S.A.V., with INZELM 20mg tablets (Vonoprazan) of Takeda Pharmaceutical Company Limited 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
- 30
- 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 Vonoprazan 20 mg Tablets by Laboratorios Leti, S.A.V., with INZELM 20mg tablets (Vonoprazan) of Takeda Pharmaceutical Company Limited in healthy adult human subjects under fasting conditions.
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Vonoprazan 20 mg Tablets by Laboratorios Leti, S.A.V., with INZELM 20mg tablets (Vonoprazan) of Takeda Pharmaceutical Company Limited in healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Vonoprazan 20 mg Tablets in healthy adult human subjects under fasting conditions.
Number of subjects: Thirty (30) subjects
Duration of clinical study: 08 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
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
- •History 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, AUC0-t and AUC0-∞
时间窗: From Day 01 to Day 08
次要结局
- To evaluate Pharmacokinetics parameters:Tmax, AUC_%Extrap_obs, λz and t1/2(From Day 01 to Day 08)
研究者
Dr Ankita Das
ICBio Clinical Research Private limited