Bioequivalence Study of Two MN-166 (Ibudilast) 50 mg Extended Release Tablet Formulations Compared With MN-166 (Ibudilast) 10mg Capsules in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- MediciNova
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Compare the PK Profile of two new formulations in Single-day dose of MN-166
研究概览
简要总结
To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers
详细描述
Part 1:
To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers; and To choose one of the two MN-166 50mg ER tablet formulations for evaluation in Part 2.
Secondary: To determine the safety and tolerability of the two formulations of MN-166 ER tablets in a single-dose regimen in healthy volunteers.
Part 2:
To compare the bioavailability and steady-state pharmacokinetic profile of MN-166 50mg ER tablet with MN-166 10mg capsules in a multiple-dose regimen in healthy volunteers; and
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent.
- •Healthy non-smoking male and female subjects aged 18 to 65 years, inclusive.
- •No clinical abnormalities in laboratory and urine analyses.
- •Normal renal function (GFR > 90mL/min).
- •Liver enzymes should be less than twice the upper limit of normal (ULN).
- •Screening electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits.
- •Agree to use barrier contraceptive methods during the course of the study (hormonal contraceptive alone is not acceptable).
- •Females of child-bearing potential must have a negative pregnancy test on Study Day 1.
排除标准
- •Known hypersensitivity to Pinatos® or its components.
- •Condition(s) which might affect drug absorption, metabolism or excretion.
- •Untreated mental illness, current drug addiction or abuse or alcoholism.
- •Donated blood in the past 90 days or have poor peripheral venous access.
- •Platelets < l00,000/mm3, history of thrombocytopenia.
- •Confirmed diagnosis of chronic liver disease, e.g., chronic Hep. B, Hep. C infection, auto-immune, alcoholic or neoplastic liver disease.
- •Positive serostatus for HIV.
- •Currently pregnant or nursing.
- •History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric diseases.
- •Received an investigational drug in the past 30 days.
- •Unable to swallow tablets.
研究组 & 干预措施
Extended-release formulation 1 (ER1)
50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
干预措施: MN-166 (Drug)
Extended-release formulation 2 (ER2)
50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release.
干预措施: MN-166 (Drug)
Intermediate-release formulation (IR)
10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release.
干预措施: MN-166 (Drug)
结局指标
主要结局
Compare the PK Profile of two new formulations in Single-day dose of MN-166
时间窗: 5 weeks
Compare the maximum plasma concentrations \[Cmax\] of MN-166 of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers.
次要结局
- Compare the incidence of treatment-emergent adverse events of two new formulations in Single-day dose of MN-166(5 weeks)
- Compare the incidence of treatment-emergent adverse events of two new formulations in Multi-day dose of MN-166(3 weeks)
- Compare the PK Profile of two new formulations in Multi-day dose of MN-166(3 weeks)