An Open, Randomized, Single-dose, Two-way Crossover Study to Characterize the Pharmacokinetic Properties of Cyanocobalamin When Administered as an Intranasal Spray and an Intramuscular Injection to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Relative bioavailability
研究概览
简要总结
The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).
详细描述
This is an open-label, randomized, single-dose, two-way crossover study. The study consists of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two confinement periods will be separated by a washout period of at least 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male voluteers
- •18-40 years of age
- •BMI between 18.5 and 30.0 kg/m2
排除标准
- •Females who are pregnant or lactating
- •History of clinically significant metabolic, hepatic, renal, haematological, pulmondary, cardiovascular, gastrointestinal, urological, neurological or phychiatric disorders
- •Serum vitamin B12 <=250 pmol/L or MMA >=0.40 umol/L
- •Evidence of significant intranasal pathology
- •Nasal congestion, allergic rhinitis or upper respiratory tract infection
研究组 & 干预措施
Nascobal nasal spray (cyanocobalamin USP)
One single administration of intranasal cyanocobalamin (initially)
干预措施: Nascobal nasal spray (cyanocobalamin, USP) (Drug)
Vitamin B12-ratiopharm N, injection solution
One single injection of IM cyanocobalamin (initially)
干预措施: Vitamin B12-ratiopharm N, injection solution (Drug)
结局指标
主要结局
Relative bioavailability
时间窗: 0-72 hours
Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.
次要结局
- Additional PK characteristics(0-72h)