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 capsuleï?¢ 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) of Sanofi-Aventis in healthy, adult, human subjects under fasting condition

The ACME Laboratories Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•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

•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

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