PACTR202201760181404已完成1 期
A COMPARATIVE, SINGLE CENTER, OPEN-LABEL, LABORATORY-BLIND, RANDOMIZED, FOUR PERIOD CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF AN IMMEDIATE RELEASE TABLET FORMULATION CONTAINING 500 MG FLUCYTOSINE AND THREE SUSTAINED RELEASE PELLET FORMULATIONS OF FLUCYTOSINE IN HEALTHY MALES AND FEMALES UNDER FASTING CONDITIONS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Healthy males and females, 18 to 55 years (both inclusive) at the time of signing of informed consent.
- •Body mass index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
- •Body weight not less than 50 kg for males and females.
- •Medical history, vital signs, physical examination, standard 12-lead ECG, including QT interval corrected with the Fridericia formula (QTcF) measure of =450 msec, and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
- •Normal blood pressure (BP): Systolic BP between 90 and 140 (160 if > 45 years old) mmHg (inclusive), diastolic BP 45 to 90 mmHg (inclusive), measured after 10 min rest in supine position.
- •Non-smokers or mild to moderate smokers (= 10 cigarettes or pipes per day).
- •Females, if:
- •Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for = 12 months and considered post-menopausal (following follicle stimulating hormone [FSH] quantification).
- •Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated once within a 1 week after the original test to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
- •Of childbearing potential, the following conditions are to be met:
- •-Negative pregnancy test.
- •If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IP, every attempt must be made to follow her to term.
- •-Not breastfeeding and must agree not to breastfeed while participating in the study and for up to 1 month after discontinuation of the treatment.
- •-Abstaining from sexual activity (if this is the usual lifestyle of the subject) or are in a same-sex relationship or must agree to use
排除标准
- •Evidence of psychiatric disorder, antagonistic functioning, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- •Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females (1 unit is equal to approximately 330 mL of beer, one small glass [200 mL] of wine, or one measure [25 mL] of spirits).
- •Regular exposure to substances of abuse (other than alcohol) within the past year.
- •Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IP except if this will not affect the outcome of the study in the opinion of the investigator.
- •Participation in another study with an experimental drug, where the last administration of the previous IP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin, whichever is the longer) before administration of IP in this study.
- •Treatment within the previous 3 months before the first administration of IP with any drug with a well defined potential for adversely affecting a major organ or system.
- •Treatment with potent inhibitors of dihydropyrimidine dehydrogenase (DPD) in the previous 4 weeks: Antiviral antiherpetic nucleoside agents (e.g. brivudine, sorivudine and their analogues) or Uracil.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Treatment with a not recommended and contraindicated medication as per SmPC within 2 weeks before the first administration of IP.
- •A major illness during the 3 months before commencement of the screening period.
- •History of hypersensitivity or allergy to the IP or its excipients or any related medication.
- •History of bronchial asthma or any other bronchospastic disease.
- •History of convulsions.
- •History of porphyria.
- •Relevant history or laboratory or clinical findings
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