An open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on fixed dose combination of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet from SciTech Specialities Pvt. Ltd. (Test) Vs Tramacet® 37.5 mg/325 mg effervescent tablet (Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg) of Grunenthal GmbH (Reference), 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
- 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 oral dose,crossover, bioequivalence study on fixed dose combination of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescenttabletfrom SciTech Specialities Pvt. Ltd. (Test) Vs Tramacet®37.5 mg/325 mg effervescent tablet (Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg) of Grunenthal GmbH (Reference),in healthy, adult, human subjects under fasting conditions.
Primary objective:
To compare rateand extend of orally administered molecule to find out concentration onbiological fluid of fixed dose combination of Tramadolhydrochloride 37.5 mg and Acetaminophen 325 mgeffervescent tablet from SciTech Specialities Pvt. Ltd. (Test) Vs Tramacet® 37.5 mg/325 mg effervescent tablet (Tramadolhydrochloride 37.5 mg and Acetaminophen 325 mg) of Grunenthal GmbH(Reference), in healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety and tolerability of thestudy subjects after administration of Tramadolhydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet in healthy adult human subjects under fastingconditions.
24 Subject will be enroll 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).
- •5.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.
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.
- •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, AUC0-t and AUC0-∞
时间窗: Day 1 to day 3
次要结局
- Tmax , AUC_%Extrap_obs, λz and t1/2(Day 1 to day 3)