NCT05129137已完成1 期
Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) and Individual Nefopam Hydrochloride and Paracetamol Taken Alone or Concomitantly After Oral Single Dose
Unither Pharmaceuticals, France1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年11月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
研究概览
简要总结
This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and non-pregnant female human subjects, age 18 - 45 years.
- •Body Mass Index between 18.5-30 Kg / m2 .
- •Subjects with normal findings .
- •Willingness to follow the protocol requirements
排除标准
- •Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
- •Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- •Subjects with a history of convulsive disorders.
- •Subject with a moderate or severe renal impairment
- •History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •Female subjects not confirming to using birth control measures,
研究组 & 干预措施
nefopam hydrochloride 30mg
Active Comparator
Single dose: 2 tablets
干预措施: nefopam hydrochloride 30mg X2 (Drug)
paracetamol 500mg
Active Comparator
Single dose: 2 tablets
干预措施: paracetamol 500 mg X2 (Drug)
nefopam hydrochloride 30mg and paracetamol 500mg
Active Comparator
Single dose: 2 tablets
干预措施: nefopam hydrochloride 30mg X2 (Drug)
nefopam hydrochloride 30mg and paracetamol 500mg
Active Comparator
Single dose: 2 tablets
干预措施: paracetamol 500 mg X2 (Drug)
结局指标
主要结局
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
时间窗: up to 48 hours post dose
Area under the plasma concentration versus time curve (AUC) of nefopam hydrochloride and paracetamol after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours
次要结局
- Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose(up to 48 hours post dose)
- N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose(up to 48 hours post dose)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 48 hours)
研究者
研究点 (1)
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