NL-OMON41076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 sildenafil after a single oral administration of Lybrido in healthy female subjects - Lybrido 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. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study;
- •2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;
- •3. Females between 18 and 55 years of age (both inclusive);
- •4. Healthy based on medical history, physical examination, electrocardiogram, laboratory values and vital signs;
- •5. Body mass index (BMI) >=18 kg/m2 and <= 30 kg/m2;
- •6. Venous access sufficient to allow blood sampling as per protocol;
排除标准
- •Cardiovascular conditions;
- •1. History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months;
- •2. Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality as observed on electrocardiogram (ECG);
- •3. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg;
- •4. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure< 50 mmHg;
- •5. Use of oral contraceptives containing anti-androgens (e.g. crypteron acetate) or anti (androgenic) progestogens (drosperidone, dienogest, chlormadinone acetate and norgestrel);6. Use of any hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen;
- •7. Pregnancy (note: an urine pregnancy test will be performed in all women prior to the administration of study medication);
- •8. Lactating or delivery in the previous 6 months;
- •9. 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 age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms);
- •10. Liver and/or renal insufficiency;
- •11. Current clinically relevant endocrine disease;
- •12. Positive serology for HIV, Hepatitis B (surface antigen), and/or Hepatitis C;
- •13. Substance abuse disorder;
- •14. Use of nitrates or nitric oxide donor compounds;
- •15. Subjects who are taking potent CYP3A4 inhibitors or inducers;
- •16. Use of serotonergic drugs (e.g. Trazodon, fluvoxamide);17. Use of testosterone therapy within 6 months before study entry;
- •18. Use of any medication that interferes with study medication (e.g. monoamine oxidase (MAO) inhibitors, calcium channel blockers);
- •19. Illiteracy, unwillingness or inability to follow study procedures;
- •20. Participation in any other clinical drug study in the previous 3 months;
研究者
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