EUCTR2012-000855-15-Outside-EU/EEA进行中（未招募）不适用
An open label, randomized, three period, single-dose, crossover study to determine the bioavailability of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition and to evaluate the effect of food on the pharmacokinetics of 300 mg aliskiren minitablets in healthy subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •- Light smokers (< 5 cigarettes/ beedies per day).
- •- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
- •For a full list of inclusion criteria please refer to the full protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- •- Participation in any clinical investigation within four (4) weeks prior to initial dosing.
- •- Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing.
- •- Hemoglobin levels below 12 gm/100mL.
- •- Significant illness within two (2) weeks prior to initial dosing.
- •For a full list of exclusion criteria please refer to the protocol.
研究者
相似试验
尚未招募
1 期
A clinical trial to evaluate and compare the blood levels of aliskiren mini-tablets with aliskiren market tablet under fasted condition and futher evaluate aliskiren mini-tablets under fed condition in healthy subjectsCTRI/2009/091/000723ovartis Healthcare Private Limited69
Unknown
1 期
A study to evaluate effect of single oral dose of SDN-118 Capsules in healthy adult Human subjectsCTRI/2020/03/024009Sun Pharma Advanced Research Company Limited
进行中（未招募）
1 期
An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.ot applicable (submitted trial is a bioequivalence study in healthy subjects)MedDRA version: 20.0Level: HLGTClassification code: 10047438Term: Viral infectious disorders Class: 10021881CTIS2023-504760-42-00Dermax30
已完成
不适用
An randomly assigned, two-treatment, balanced, single dose study to evaluate the Pharmacokinetics and Pharmacodynamics of Intravenous Injection of REPOITIN and Human Serum Albumin - Free REPOITIN Injection of Serum Institute compared to licensed EPO injection injection in healthy adult subjectsCTRI/2015/11/006383Serum Institute of India Ltd66
已完成
不适用
An randomly assigned, two-treatment, balanced, single dose study to evaluate the Pharmacokinetics and Pharmacodynamics of subcutaneous Injection of REPOITIN and Human Serum Albumin - Free REPOITIN Injection of Serum Institute compared to licensed EPO injection injection in healthy adult subjectsCTRI/2015/04/005670Serum Institute of India Ltd48