An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Uropass capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) of The ACME Laboratories Ltd., in comparison with Flomax capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) of Sanofi-Aventis in healthy, adult, human subjects under fasting condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters Cmax AUC0-t and AUC0- ∞ will be checked
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 Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of The ACME Laboratories Ltd in comparison with Flomax capsuleâ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of Sanofi Aventis in healthy adult human subjects under fasting condition
Primary objective
To compare the rate and extent of absorption of Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of The ACME Laboratories Ltd with that of Flomax capsuleâ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of Sanofi Aventis in healthy adult human subjects under fasting condition
Secondary objective
To monitor the safety and tolerability of the study subjects after administration of Tamsulosin 0.4 mg capsules in healthy adult human subjects under fasting condition
Twenty four 24 normal healthy adult human subjects will be enrolled for the conduct of bioequivalence study
Study duration for BE study of Tamsulosin Hydrochloride 0.4 mg capsule will not exceed 9 days period I check in to last visit of period II
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
- •1Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2Willing to be available for the entire study period and to comply with protocol requirements 3Normal healthy adult human subject of 18 45 years both inclusive of age 4Body mass index in the range of 18 30 kg/m2 both inclusive 5Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician.
排除标准
- •1Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs 2History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past 3History of severe infection or major surgery in the past 6 months 4History of Minor surgery or fracture within the past 3 months 5Significant 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 6Any major illness or hospitalization within 90 days prior to check in of first period 7Any other clinical condition like diarrhea or vomiting within three days prior to check in of any period.
结局指标
主要结局
Pharmacokinetic parameters Cmax AUC0-t and AUC0- ∞ will be checked
时间窗: From baseline Day 01 to day 10 after the dosing
次要结局
- Pharmacokinetic parameters as Tmax AUC_%Extrap_obs λz and t1/2 will be evaluated(From baseline Day 01 to day 04 after dosing)