An Open label, balanced, randomized, truncated, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Posaconazole 100 mg gastro-resistant tablets of Signature Phytochemical Industries with NoxafilÂ® 100 mg gastro-resistant tablets (Posaconazole 100 mg) of Merck sharp & Dohme (New Zealand) Limited in healthy adult human subjects under fasting conditions.

Signature Phytochemical Industries0 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

研究概览

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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).
•5 Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12 to 16 g/dL for female.

•1 Found positive (+ve) on rapid 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.
•5 History of severe infection or major surgery in the past 6 months.
•6 History of Minor surgery or fracture within the past 3 months

发起方