EUCTR2012-004900-37-GB进行中（未招募）不适用
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel group study to assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral Rupatadine in Healthy Japanese Subjects after Single and Multiple Ascending Doses
J. Uriach y Compañía, S.A.0 个研究点开始时间: 2012年11月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Healthy male or female Japanese subject, aged 20 - 45 years, inclusive, at screening.
- •Japanese subjects must meet the following criteria: i) born in Japan to both
- •Japanese parents and grandparents; ii) lived less than 5 years outside of Japan;
- •iii) no significant change in lifestyle, including diet, since leaving Japan
- •2. Subject has a Body Mass Index (BMI) of 18 – 25 kg/m2 inclusive at screening.
- •3. Subjects must agree to use acceptable methods of contraception:
- •If female, subjects of childbearing potential must agree to use medically acceptable
- •methods of contraception from the time of signing the informed consent until 3 months following administration of the last treatment or dose of study medication as
- •outlined in the protocol. Male subjects must utilise at least one of the methods outlined in the protocol.
- •4. All subjects included in the study must meet the ECG screening selection criteria.
- •ECG criteria to be signed off for inclusion by a cardiologist (if applicable).
- •5. Subjects must be capable of understanding and complying with the requirements of
- •the protocol and must have signed the informed consent form prior to undergoing
- •any study-related procedures.
- •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 27
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be prohibited from participation in this clinical study if they meet any of the
- •following criteria at the screening and/or admission visits:
- •1. Subject has a clinically significant disease or any condition or disease that might affect
- •drug absorption, distribution or excretion.
- •2. Any clinically significant abnormal laboratory, vital signs or other safety findings as
- •determined by medical history, physical examination or other evaluations conducted at
- •screening or on admission.
- •3. Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening)
- •which in the opinion of the Investigator is clinically relevant or will interfere with the
- •ECG analysis.
- •4. History or current evidence of any clinically relevant cardiovascular, pulmonary,
- •hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic,
- •neurological, psychiatric or other disease.
- •5. Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg),
- •anti-Hepatitis core antibody (anti-HBc Ig G [and anti-HBc IgM if IgG is positive],
- •Hepatitis C antibodies (anti-HCV), and Human Immunodeficiency Virus (HIV) 1 and 2
- •antibodies, (anti-HIV 1/2).
- •6. Confirmed positive results from urine drug screen (amphetamines, benzodiazepines,
- •cocaine, cannabinoids, opiates, barbiturates, and methadone) or from the alcohol
- •breath test at screening and on admission (Day -1).
- •7. History or clinical evidence of alcohol or drug abuse. Alcohol abuse is defined as
- •regular weekly intake of more than 21 units (Using alcohol tracker
- •http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx); drug abuse is defined as
- •compulsive, repetitive and/or chronic use of drugs or other substances with or without
- •problems related to their use and/or where stopping or a reduction in dose will lead to
- •withdrawal symptoms.
- •8. Mentally handicapped.
- •9. Participation in a drug trial within 90 days prior to first drug administration.
- •10. Use of any medication (including over-the-counter (OTC) medication) within 2 weeks
- •prior to admission (Day -1) or within less than 10 times the elimination half-life of the
- •respective drug, or anticipated concomitant medication during the treatment periods.
- •Single intake of a drug may be accepted if judged by the investigators to have no
- •clinical relevance and no relevance for the trial objectives.
- •11. Use of any substance inhibiting CYP3A4 enzymes within 2 weeks prior to admission
- •(Day -2).
- •12. Donation of more than 500 mL of blood within 90 days prior to drug administration.
- •13. Subjects who smoke more than 10 cigarettes or equivalent amount of tobacco per day
- •and/or who cannot stop smoking for the duration of the study whilst in the CPU.
- •14. Treatment with herbal supplements during the 7 days prior to dosing, or use of vitamins
- •during 48 hours prior to admission to the CPU (Day -2).
- •15. Any circumstances or conditions, which, in the opinion of the PI, may affect full
- •participation in the trial or compliance with the protocol.
- •16. Legal incapacity or limited legal capacity at screening.
- •17. Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with
- •the study standardised menus.
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