An Open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries versus Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) of Hetero Labs Limited in healthy adult human subjects under fasting conditions - NA

Signature Phytochemical Industries0 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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•1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 18-55 years (both inclusive) of age.
•4.Body mass index in the range of 18 â??30 kg/m2 (both inclusive)

•1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening.
•2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
•3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs.
•4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.

发起方