EUCTR2014-004350-34-Outside-EU/EEA进行中（未招募）不适用
A Comparative Bioavailability Study of a Tablet versus an InvestigationalOral Suspension of Vorapaxar - PK of Pediatric Formulation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc0 个研究点目标入组 24 人开始时间: 2014年10月29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
- 入组人数
- 24
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, non-smoking, male and female subjects, from 18 to 55
- •years of age.
- •2) BMI = 19.0 and =30.0 kg/m2 and weight =60 kg.
- •3) No clinically significant findings in vital-signs measurements.
- •4) No clinically significant abnormal laboratory values.
- •5) No clinically significant findings in a 12-lead electrocardiogram
- •6) Have no significant diseases.
- •7) Willing to use an acceptable, effective method of contraception.
- •8) Be informed of the nature of the study and give written consent
- •prior to any study procedure.
- •9) Have no clinically significant findings from a physical examination.
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Known history or presence of any clinically significant medical
- •2) Known or suspected carcinoma.
- •3) History of stroke, myocardial infarction (MI), transient ischemic
- •attack (TIA), peripheral arterial disease (PAD) or intracranial
- •hemorrhage (ICH).
- •4) Known history or presence of active clinically
- •significant/pathological bleeding (e.g., peptic ulcer, intracranial
- •hemorrhage, clotting disorders).
- •5) Known history or presence of galactose or fructose intolerance,
- •sucrase-isomaltase insufficiency, Lapp lactase insufficiency,
- •galactosemia, or glucose-galactose malabsorption syndrome.
- •6) Subjects with mouth piercings, dentures, braces, dental appliances,
- •or any other alteration to the mouth that may compromise drug
- •9) Presence of clinically significant gastrointestinal disease or history
- •of malabsorption within the last year.
- •10) Presence of a medical condition requiring regular medication
- •(prescription and/or over-the-counter) with systemic absorption.
- •11) History of drug or alcohol addiction requiring treatment.
- •12) Positive test result for HIV, Hepatitis B surface antigen or Hepatitis
- •C antibody.
- •13) Positive test result for urine drugs of abuse (cannabinoids, opiates,
- •amphetamines, cocaine, phencyclidine, tricyclic antidepressants,
- •barbiturates, methadone and benzodiazepines) or urine cotinine.
- •14) Difficulty fasting or consuming standard meals.
- •15) Does not tolerate venipuncture.
- •16) Use of tobacco or nicotine-containing products within 6 months
- •prior to drug administration.
- •17) On a special diet within 30 days prior to drug administration (e.g.,
- •liquid, protein, raw food diet).
- •18) Participated in a clinical trial, which involved administration of an
- •investigational medicinal product within 30 days prior to drug
- •administration, or recently participated in a clinical investigation that,
- •in the opinion of the Investigator, would jeopardize subject safety or
- •the integrity of the study results.
- •19) Donation or loss of whole blood (including clinical trials):
- •= 50 mL and = 499 mL within 30 days prior to drug administration;
- •= 500 mL within 56 days prior to drug administration.
- •20) Females who:
- •Have used oral or transdermal hormonal contraceptives within 21
- •days prior to drug administration;
- •Have used implanted, injected, intravaginal or intrauterine hormonal
- •contraceptives within 6 months prior to drug administration;
- •Are pregnant (serum hCG consistent with pregnancy); or
- •Are lactating.
- •21) Have had a tattoo or body piercing within 30 days prior to drug
- •administration.
- •22) Estimated creatinine clearance of =80 mL/min based on the
- •Cockcroft-Gault equation.
- •23) Known history or presence of hypersensitivity or idiosyncratic
- •reaction to vorapaxar (MK-5348) or any other drug substances with
- 另有 12 项未显示
研究者
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