NCT03245918已完成1 期
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers
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
- 17
- 试验地点
- 1
- 主要终点
- Bioavailability of the oral suspension relative to the capsule
研究概览
简要总结
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects as determined by responsible physician (see 4.3) (i.e. have no clinically significant diseases captured in the medical history, on physical examination and/or laboratory tests)
- •18 to 55 years of age
- •BMI within 18.5 to 30 kg/m2
- •Non-smoker
- •Systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90 mmHg, and heart rate between 60-100 bpm, inclusive.
- •Female subjects of childbearing potential should be either sexually inactive (abstinent) or be using one of acceptable methods of birth control for 15 days prior to the first dose of the study, throughout the study and for at least 30 days after the last aprepitant dose.
- •Able to swallow whole aprepitant capsules
- •Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer.
排除标准
- •Clinically significant illness or surgery within 8 weeks prior to dosing.
- •Positive for hepatitis B, hepatitis C, or HIV at screening as per medical history.
- •History of allergic reactions to the study drug and/or its excipients.
- •Subjects concurrently treated with drugs that are metabolized through CYP3A4, including but not limited to pimozide, terfenadine, astemizole, or cisapride, ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin, carbamazepine, and phenytoin etc.
- •History of drug or alcohol abuse within the last 6 months.
- •Severe mental disorders.
- •Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
- •Pregnant or breastfeeding.
- •Use of recreational drugs, prescription medications (other than hormonal contraceptive agents),non-prescription medications (over-the-counter) or natural health products within 7 days or 5 half-lives (whichever is longer) prior to the administration of the first dose of study medication.
- •Consumed grapefruit or grapefruit products within 7 days of each study period
- •Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
Aprepitant Capsule Study Period #1
Other
干预措施: Aprepitant Capsule 125 MG (Drug)
Aprepitant Oral Suspension Study Period#1
Other
干预措施: Aprepitant oral suspension 20 mg/mL (Drug)
结局指标
主要结局
Bioavailability of the oral suspension relative to the capsule
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Lee Dupuis
Health Clinician Scientist
The Hospital for Sick Children
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced NauseaBreast CancerNCT04937309University Hospital, Tours338
已完成
3 期
Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving ChemotherapyChemotherapy Induced Nausea and VomitingNCT01402024All India Institute of Medical Sciences, New Delhi96
已完成
不适用
ow emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational studyJPRN-UMIN000020800Commitee of academic, society of pharmacist in national hospital organization kyushu200
Unknown
早期 1 期
Effectiveness of Medical Taping Concept in Cancer PatientsCancer-related Problem/ConditionNCT02823314Universidad Miguel Hernandez de Elche20
已完成
2 期
Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction ChemotherapyAcute Myeloid LeukemiaNCT01334086University Health Network, Toronto41