NL-OMON41098已完成不适用
A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of buspirone after a single oral administration of Lybridos in healthy female subjects - Lybridos Food Effect
EB FlevoResearch BV0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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
- 18 至 99（—）
入选标准
- •1. Provision of written informed consent
- •2. Females between 18 and 55 years of age (both inclusive)
- •3. Healthy based on medical history, physical examination, electrocardiogram, laboratory values and vital signs
- •4. Body mass index (BMI) >=18 kg/m2 and <= 30 kg/m2
- •5. Venous access sufficient to allow blood sampling as per protocol;
排除标准
- •1. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg
- •2. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure< 50 mmHg
- •3. Use of oral contraceptive containing anti-androgens (e.g. cyproteron) or anti(androgenic) progestogens (drospirone, dienogest, chlormadinone acetate and norgestrel)
- •4. Use of any or hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen
- •5. Pregnancy (note: an urine pregnancy test will be performed in all women prior to the administration of study medication)
- •6. Lactating or delivery in the previous 6 months
- •7. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night contraceptive sweating) in combination with elevated FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms)
- •8. Use of any drugs from two weeks prior to admission to the research unit until the follow-up visit, except for allowed oral contraceptives and pain relief (e.g. paracetamol up to 1.5 g per day)
- •9. Known or suspected hypersensitivity to any of the components of the formulation
- •10. Liver function tests (i.e., ALT, AST and bilirubin) significantly above the upper limit of normal at repeated measures
- •11. Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
- •12. Smoking
- •13. Unwilling or unable to refrain from consuming grapefruit juice, star fruit, and St. Johns Wort 24 hours before and after intake of medication
- •14. Current regular use of any illicit drugs or history of excessive drinking within 3 months prior to admission to the research unit and/or unwilling or unable to refrain from products containing alcohol from 24 hours before admission and during the stay in the research unit
- •15. Donation of blood within 3 months prior to admission to the research unit
- •16. Positive serology test for HBsAg, anti HAV (IgM), anti HCV or anti HIV 1+2
- •17. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason
- •18. Participation in any clinical study within 1 month prior to the expected date of enrolment into the study.
- •19. Employees of the sponsor or CRO involved in the study
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