An Open-label, Multiple Dose, Randomized, Three-period Crossover Study in Healthy Subjects to Evaluate the Effect of Co-administration of Oseltamivir (Ro 64-0796) 75 mg Twice Daily and Rimantadine 100 mg Twice Daily on the Pharmacokinetic Properties of Oseltamivir and Rimantadine.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate
研究概览
简要总结
This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between treatments. Anticipated time on study is up to 11 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults, aged 18 to 45 years
- •Healthy as judged by general physical examination, medical history, vital signs, 12-lead ECG and laboratory tests
- •Body Mass Index (BMI) 18-34 kg/m2
- •Willing not to participate in any other trial including an investigational drug for 3 months following the last dose
- •Male subjects must agree to use a barrier contraception during the study and for 3 months after discontinuation of treatment
- •Female subjects of non-child bearing potential or under effective contraception who are either post-menopausal, surgically sterile, or who agree to use barrier contraception during the whole study in addition to an intrauterine device or hormonal contraception for at least 3 months prior to 1st dose, during the study and for 3 months after discontinuation of treatment
排除标准
- •History of or current clinically significant disease or disorder
- •Positive Hepatitis B, Hepatitis C, HIV 1 or 2 test result
- •Positive pregnancy test or lactating women
- •Clinically relevant history of allergy or hypersensitivity
- •Clinically relevant history of abuse of alcohol or other drugs; tobacco smoking is allowed (</= 10 cigarettes a day or equivalent of tobacco in cigars or pipe)
- •Any major illness within 30 days prior to screening examination
- •Administration of any medication during the 7 days prior to drug administration, except for paracetamol and aspirin (up to 48 hours before first dose) and oral contraceptives
- •Participation in a clinical study with an investigational drug within 3 months prior to study day 1
- •Donation or loss of more than 500 mL of blood within the 3 months prior to study day 1
研究组 & 干预措施
A
干预措施: oseltamivir [Tamiflu] (Drug)
B
干预措施: rimantadine (Drug)
C
干预措施: oseltamivir [Tamiflu] (Drug)
C
干预措施: rimantadine (Drug)
结局指标
主要结局
Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate
时间窗: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5
Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.
Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine
时间窗: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5
AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.
次要结局
- Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate(Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5)
- Number of Participants With Clinically Significant or Treatment Related Changes in Electrocardiogram (ECG)(Screening; pre-dose on Day 1 and Day 5 of each treatment period; Follow-up visit)
- Number of Participants With Abnormal Vital Signs(Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature)
- Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)(Up to 11 weeks)
- Number of Participants With Marked Abnormality in Laboratory Parameters(Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit)
- Maximum Plasma Concentration (Cmax) of Rimantadine(Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5)