An Open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on BILSYN – M tablet (Bilastine 20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare rate and extend of orally administered molecule to prove bioequivalence on BILSYN – M tablet (Bilastine 20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adult human subjects under fasting conditions.
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 BILSYN – M tablet (Bilastine 20 mg andMontelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adulthuman subjects under fasting conditions.
24 Subjects will be enrolled in the study.
The study objective
Primary objective:
To compare rateand extend of orally administered molecule to prove bioequivalence on BILSYN –M tablet (Bilastine20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg andMontelukast 10 mg) of Glenmark PharmaceuticalsLtd., in 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.
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
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •Willing to be available for the entire study period and to comply with protocol requirements.
- •Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- •Body mass index in the range of 18 –25 kg/m2 (both inclusive).
- •Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female.
- •Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
- •With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no.
- •With a normal or clinically non-significant 12-lead ECG.
- •With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
排除标准
- •Found +ve PCR test for COVID-19 during screening.
- •Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
- •Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
- •History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •History of severe infection or major surgery in the past 6 months.
- •History of Minor surgery or fracture within the past 3 months.
结局指标
主要结局
To compare rate and extend of orally administered molecule to prove bioequivalence on BILSYN – M tablet (Bilastine 20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adult human subjects under fasting conditions.
时间窗: Day 1 to Day 12
次要结局
- To monitor the safety of the study subjects after administration of Bilastine and Montelukast in healthy adult human subjects under fasting conditions.(Day 1 to Day 12)