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
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, AUC0-t and AUC0-∞
研究概览
简要总结
An Open label,balanced, randomized, two-treatment, two-sequence, two-period, single oraldose, crossover, bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tabletof Signature Phytochemical Industries versus Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) of HeteroLabs Limited in healthy adult human subjects under fasting conditions.
Primary objective:
To compare rateand extend of orally administered molecule to prove bioequivalence on Bilastine20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries versusBilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) of Hetero Labs Limitedin healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety of the study subjectsafter administration of Bilastine 20 mg andMontelukast 10 mg tablet in healthy adult human subjects under fastingconditions.
24 Subjects will be enrolled in the study .
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).
排除标准
- •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 blood–forming organs.
- •4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
结局指标
主要结局
Cmax, AUC0-t and AUC0-∞
时间窗: from day 1 to 12
次要结局
- Tmax , AUC_%Extrap_obs, λz and t1/2(from day 1 to 12)