An Open-Label, Single-Dose Study to Assess the Safety of 500-mg Mebendazole Chewable Formulation in Children 2 to 10 Years of Age, Inclusive

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.0 个研究点目标入组 397 人开始时间: 2015年4月9日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•- Be an otherwise healthy child based on medical history, physical examination, vital signs, and concomitant medications and live in a high-prevalence area where parasite infection is endemic (ie, Prevalent in or peculiar to a particular locality, region, or people)
•- Have teeth and be able to chew the mebendazole chewable tablet
•- Girls must be premenarchal
•- Parent(s)/guardians of study participants (or their legally-accepted representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 397
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Have a history of clinically significant liver or renal insufficiency
•- cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (eg, anemia), rheumatologic, psychiatric, or metabolic disturbances that, in the opinion of the investigator, renders the candidate not suitable for mebendazole treatment
•- Have a suspected massive intestinal parasitic infection, based on history and physical findings, as determined by the principal investigator
•- Have any condition that, in the opinion of the investigator, would compromise the well-being of the study participant or the study or prevent the study participant from meeting or performing study requirements

发起方