An open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Bilastine 10 mg and Montelukast 4 mg per 5ml oral suspension of Rivpra Formulation Pvt. ltd., in comparison with Bilafav-M Suspension 10mg/4mg per 5 ml (Bilastine 10 mg and Montelukast 4 mg) of Synokem Pharmaceuticals Ltd., in healthy, adult, human subjects under fasting conditions. - NIl

RIVPRA FORMULATION PVT LTD0 个研究点目标入组 23 人开始时间: 待定最近更新: 2023年4月3日

试验速览

暂无简介。

•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 â?? 30 kg/m2
•5.Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.
•6.Normal health status as determined by medical history and physical examination by the PI/CI/Physician at the time of screening and vital signs

•1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.
•2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
•3.History of severe infection or major surgery in the past 6 months.
•4.History of Minor surgery or fracture within the past 3 months.
•5.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.
•6.Any major illness or hospitalization within 90 days prior to check-in of first period.

发起方

RIVPRA FORMULATION PVT LTD