NL-OMON39942
已完成
不适用
Bioequivalence study in healthy volunteers of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase I (VALID I) - VALID I
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 16 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 10047438
- 发起方
- niversitair Medisch Centrum Sint Radboud
- 入组人数
- 16
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Subject is at least 18 and not older than 55 years of age at screening.
- •2\. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing
- •3\. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
- •4\. Subject has signed the Informed Consent Form prior to screening evaluations.
- •5\. Subject is in good age\-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly re\-corded.
- •6\. Subject has a normal blood pressure and pulse rate, according to the investigator's judgement.
- •7\. Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or is of childbearing potential with adequate contraception (e.g. hysterectomy, bilateral tubal ligation, (nonhormonal) intrauterine device, total abstinence, double barrier methods, vasectomized partner).
排除标准
- •1\. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •2\. Positive HIV, hepatitis B or C test.
- •3\. Therapy with any drug (for two weeks preceding dosing), except for acetaminophen.
- •4\. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disor\-ders, neurological disorders (especially seizures and migraine), gastro\-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
- •5\. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •6\. History of or current abuse of drugs, alcohol or solvents.
- •7\. Inability to understand the nature and extent of the trial and the procedures required.
- •8\. Participation in a drug trial within 60 days prior to the first dose.
- •9\. Donation of blood within 60 days prior to the first dose.
- •10\. Febrile illness within 3 days before the first dose.
结局指标
主要结局
未指定
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