An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of ALGOLIDER 100 mg granules (Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA, Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate Pharmacokinetics parameters: Cmax, AUC0-t and AUC0-∞.
研究概览
简要总结
STUDY TITLE:
An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of ALGOLIDER 100 mg granules (Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA, Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions.
OBJECTIVES:
Primary objective:
To compare rate and extent of absorption of ALGOLIDER 100 mg granules (Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA, Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions.
Secondary objective:
To monitor or assess safety and tolerability of the investigational products in healthy adult human subjects under fed conditions.
Number of subjects: Twenty-four (24) subjects
Duration of clinical study: 10 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 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 18.5 – 30.0 kg/m2 (both inclusive).
- •Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, and axillary temperature) measurements at the time screening as well as check-in and check-out during each study period.
排除标准
- •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 hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
- •History of hepatotoxic reactions to Nimesulide.
- •History of Concomitant exposure to other potentially hepatotoxic substances.
结局指标
主要结局
To evaluate Pharmacokinetics parameters: Cmax, AUC0-t and AUC0-∞.
时间窗: From Day 01 to day 10
次要结局
- To evaluate Pharmacokinetics parameters: Tmax, AUC_% Extrap_obs, λz and t1/2.(From Day 01 to day 10)
研究者
Dr Ankita Das
ICBio Clinical Research Private limited