An Open label, balanced, randomized, two-treatment, twoperiod,two-sequence, single oral dose, crossover,bioequivalence study of FDC of Azelnidipine 8 mg +Telmisartan 40 mg tablet of Signature PhytochemicalIndustries with Uniaz T 40mg tablet (Azelnidipine 8 mg +Telmisartan 40 mg) of Synokem Pharmaceuticals Ltd., inhealthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
AnOpen label, balanced, randomized, two-treatment, two-period, two-sequence,single oral dose, crossover, bioequivalence study of FDC of Azelnidipine 8 mg + Telmisartan 40mg tablet of Signature Phytochemical Industries withUniaz T 40mg tablet(Azelnidipine 8 mg + Telmisartan 40mg) of Synokem Pharmaceuticals Ltd.,in healthy adult human subjects under fastingconditions.
Primaryobjective:
To compare bioequivalenceof FDC of Azelnidipine 8 mg + Telmisartan40 mg tablet of Signature Phytochemical Industries with Uniaz T 40mg tablet(Azelnidipine8 mg + Telmisartan 40 mg) ofSynokemPharmaceuticals Ltd., in healthy adult human subjects under fastingconditions.
Secondaryobjective:
To monitor and assesssafety and tolerability of the investigational products in healthy adult humansubjects 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.
结局指标
主要结局
Cmax, AUC0-t and AUC0-∞
时间窗: From day 1 and day 19
次要结局
- Tmax , AUC_%Extrap_obs, λz and t1/2(From day 1 and day 19)