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 Noxafil® 100 mg gastro-resistant tablets (Posaconazole 100 mg) of Merck sharp & Dohme (New Zealand) Limited in healthy adult human subjects under fasting conditions.
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
- Cmax, and AUC0-72
研究概览
简要总结
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 Noxafil® 100 mg gastro-resistant tablets(Posaconazole 100 mg) of Merck sharp & Dohme (New Zealand) Limited in healthy adult human subjects under fasting conditions.
Primary objective:
To compare pharmacokinetics of Posaconazole 100 mg gastro-resistant tablets of Signature Phytochemical Industries with Noxafil® 100 mg gastro-resistant tablets(Posaconazole 100 mg) of Merck sharp & Dohme (New Zealand) Limited in healthy adult human subjects under fasting conditions.Secondaryobjective:
To monitor and assess safety and tolerability of the investigationalproducts in healthy adult human subjects under fasting condition.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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 – 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.
排除标准
- •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 blood–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.
结局指标
主要结局
Cmax, and AUC0-72
时间窗: From day 1 and day 19
次要结局
- Tmax, λz and t1/2(From day 1 and day 19)