A Bioequivalence Study of the 90-mg Daclatasvir Tablet Relative to the 3 × 30-mg Daclatasvir Phase 3 Tablets, and Relative Bioavailability Studies of Chewable Pediatric Tablets of Daclatasvir and Asunaprevir in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- Maximum observed plasma concentration [Cmax]
研究概览
简要总结
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets.
Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent must be obtained from the subjects in accordance with requirements of the study center's Institutional review Board (IRB)/ Institutional Ethics Committee (IEC)
- •Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- •Age and Reproductive Status : Males and females, ages 18 to 49 years, inclusive. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study drug and must be using an acceptable method of contraception for 4 weeks prior to study drug administration. Women must not be breastfeeding.
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for duration of treatment with study drug females must still undergo pregnancy testing as described in this section.
排除标准
- •Medical History and Concurrent Diseases : Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. Any major surgery within 4 weeks of study drug administration. Any gastrointestinal surgery that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion). Inability to tolerate oral medication, smokers or recent durg or alcohol abuse and Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
- •Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population, positive urine screen for drugs, positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibodies.
- •Allergies and Adverse Drug Reaction : History of allergy to DCV, ASV, Hepatitis C virus (HCV) NS3 protease inhibitors, HCV NS5A replication cofactors, or related compounds.
研究组 & 干预措施
Group 1: Daclatasvir
Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV pediatric chewable tablet
干预措施: Daclatasvir (Drug)
Group 2: Daclatasvir
Single oral dose of Daclatasvir (DCV) pediatric chewable tablet and single oral dose of DCV pediatric chewable tablet
干预措施: Daclatasvir (Drug)
Group 3: Asunaprevir
Single oral dose of Asunaprevir (ASV) tablet, single oral dose of ASV pediatric chewable tablet and single oral dose of ASV pediatric chewable tablets
干预措施: Asunaprevir (Drug)
Group 4: Daclatasvir
Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV tablets
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Maximum observed plasma concentration [Cmax]
时间窗: Before dosing through 96 hours
AUC from time zero to the time of last quantifiable concentration [AUC(0-T)]
时间窗: Before dosing through 96 hours
Area under the concentration-time curve [AUC] from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Before dosing through 96 hours
Time of maximum observed plasma concentration [Tmax]
时间窗: Before dosing through 96 hours
Terminal plasma half life [T-HALF])
时间窗: Before dosing through 96 hours
次要结局
- Clinical laboratory tests(30 days after last dose)
- The incidence of reported AEs will be tabulated and reviewed for potential significance and clinical importance.(30 days after last dose)
- ECGs(30 days after last dose)
- Adverse Event reports(30 days after last dose)
- Vital sign measurements(30 days after last dose)
- Physical examinations(30 days after last dose)