Orfadin and Nitinosine Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Succinylacetone level
研究概览
简要总结
he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg
详细描述
Detailed Description:
The specific aim is to conduct a randomized, single dose, three-period crossover bioequivalence study in at least 18 healthy male and female subjects at a single study center to evaluate the in vivo performance of two formulations of Nitisinone 10 mg and the reference product Orfadin under fasting.
A total of 4 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to a treatment sequence, before administration of investigational nitinosine
Determination of succinylacetone (SA) in blood (serum/plasma) and/or urine will be performed. Results from samples analyzed at the central laboratory, including determination of nitisinone, will be used in the evaluation of pharmacokinetics, efficacy and safety during the two treatment periods.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All HT-1 patients receiving Orfadin treatment are eligible for entry.
- •Male and female patients of all ages diagnosed with HT-
- •Stable lab values, including liver values <2 ULN (ALP, ALT, AST, bilirubin, INR).
- •Women of childbearing potential willing to use adequate contraception
- •Signed informed consent/assent.
排除标准
- •Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •Enrollment in another concurrent clinical interventional study within three months prior to inclusion in this study.
- •Pregnant women.
- •Lactating women. .Known hepatitis B, hepatitis C or HIV infection.
- •Foreseeable inability to cooperate with given instructions or study procedures.
研究组 & 干预措施
Orfandin .5 mgm/kg mgm bid
Two participant will receive .5 mgm/kg mgm of orfadin
干预措施: Orfadin (Drug)
Nitinosine .5 mgm/kg bid
Two participant will receive .5 mgm/kg of nitinosine
干预措施: Nitisinone (Drug)
结局指标
主要结局
Succinylacetone level
时间窗: 8 weeks
Succinylacetone level will be measured every 2 weeks for eight weeks
次要结局
未报告次要终点