NCT01697436已完成1 期
A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Pharmacokinetics: maximum plasma concentration
研究概览
简要总结
This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four sequences in which they will receive the treatment under fed and under fasted conditions.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers
- •Able to participate and willing to give informed consent and comply with the study restrictions.
- •Negative urine pregnancy test (for women of childbearing potential) documented at screening and within the 24-hour period prior to each dose of test drug
- •All male subjects with female partners of childbearing potential must agree to use two reliable forms of contraception, one of which must be a physical barrier method, during the study and for 6 months thereafter
- •Female subjects must be postmenopausal or surgically sterile or they must agree to use two reliable forms of contraception one of which must be a physical barrier method, during treatment and for 6 months thereafter
- •Body mass index (BMI) <30 kg/m2
排除标准
- •Pregnant or lactating women and male partners of females who are pregnant or lactating
- •Positive test for drugs of abuse at screening and within the 24-hour period prior to each dose of test drug.
- •History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average (1 standard unit = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening and from at least 48 hours before Day -1 through the end of the study
- •Confirmed systolic blood pressure (SBP) > 140 or < 90 mm Hg, and diastolic blood pressure (DBP) > 90 or < 50 mm Hg
- •Resting pulse rate > 90 or < 45 beats per minute
- •History or symptoms of any significant disease including (but not limited to) hematological, neurological, psychiatric, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder
- •History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma of the skin (e.g., skin basal or squamous cell carcinoma)
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- •Use of any medications (prescription or over-the-counter, vitamin, mineral, herbal, and dietary supplements within 7 days, or less than 5 half-lives (whichever is longer) prior to randomization. Exceptions are acetaminophen (up to 2 g/day), ibuprofen (up to 1 g/day), and hormonal contraceptives.
- •Clinically significant abnormalities in laboratory test results
- •Participation in an investigational drug study within 60 days or in an investigational device study within 30 days prior to screening
- •Donation of blood over 500 mL from 3 months prior to screening until the end of the study; donation of plasma from 7 days prior to screening until the end of the study
- •Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study
- •Smoker of more than 10 cigarettes per day prior to screening or use of tobacco products equivalent to more than 10 cigarettes per day
- •Clinically significant abnormalities in the pre-dose resting electrocardiograms
- •Any confirmed significant allergic reactions against RBV or known or potential allergy or hypersensitivity to the non-active ingredients of the study drugs (non-active hay fever is acceptable)
- •Individuals receiving ribavirin therapy within 6 months prior to study initiation
研究组 & 干预措施
Crossover Period 1
Experimental
干预措施: ribavirin [Copegus] (Drug)
Crossover Period 2
Experimental
干预措施: ribavirin [Copegus] (Drug)
Crossover Period 3
Experimental
干预措施: ribavirin [Copegus] (Drug)
Crossover Period 4
Experimental
干预措施: ribavirin [Copegus] (Drug)
结局指标
主要结局
Pharmacokinetics: maximum plasma concentration
时间窗: Periods 1-4: Predose and up to 192 hours post-dose
Pharmacokinetics: area under the plasma concentration time curve
时间窗: Periods 1-4: Predose and up to 192 hours post-dose
次要结局
- Safety: incidence of adverse events(Approximately 16 weeks)
研究者
相似试验
已完成
1 期
Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese SubjectsHealthy VolunteerNCT03214159First Affiliated Hospital of Zhejiang University12
已完成
1 期
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese SubjectsHealthy VolunteerNCT03302182First Affiliated Hospital of Zhejiang University96
已完成
1 期
A Study Comparing Four Different Rivoceranib Tablets in Healthy ParticipantsHealthyNCT05287360Elevar Therapeutics60
已完成
1 期
Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.Schizoaffective DisordersSchizophreniaNCT00645502Johnson & Johnson Pharmaceutical Research & Development, L.L.C.40
已完成
1 期
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study ParticipantsHealthy Study ParticipantsNCT05315947UCB Biopharma SRL24