NL-OMON37493已完成不适用
A randomized, cross-over controlled study to compare the pharmacokinetic profiles of sublingual administered testosterone solution followed by a buspirone tablet, versus sublingual testosterone and buspirone combined in one tablet in healthy premenopausal women - PK-Lybridos Formulation 1 and 2
Clinical Research Organisations0 个研究点目标入组 12 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
- 12
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. Female 18-35 years of age (inclusive)
- •3. Healthy based on medical history, physical examination, 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
- •Cardiovascular conditions
- •1. Any underlying cardiovascular condition, including unstable angina pectoris
- •2. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg.
- •3. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg;Gynecological and obstetric conditions
- •4. Use of oral contraceptive containing anti-androgens (e.g. Crypteron acetate) or (anti) androgenic progesteron (drospirone, dienogest, chlormadinone acetate and norgestrel)
- •5. Use of oral contraceptive containing 50 µg estrogen or more
- •6. Pregnancy or intention to become pregnant during this study (Note: An urine pregnancy test will be performed in all women prior to the administration of study medications.)
- •7. Lactating or delivery in the previous 6 months
- •8. Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- •9. Subjects with a perimenopausal hormonal status (follicle-stimulating hormone>30);Other medical conditions
- •10. Liver- and/or renal insufficiency
- •11. Current clinically relevant endocrine disease
- •12. Current clinically relevant neurological disease which, in the opinion of investigator, would compromise the validity of study results, or which could form a contraindication for buspirone and/or testosterone use
- •13. (A history of) hormone-dependant malignancy;Psychological/psychiatric factors
- •14. A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject*s participation in the study; mild or moderate alcohol consumption is allowed but must be stopped 24 hours before the admission period. Recreational drug use is not allowed beginning 3 weeks before the start of the admission period until follow up. Smokers are not allowed to participate.;Concomitant medication
- •15. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir)
- •16. Subjects who are taking CYP3A4-inducers (eg, fenytoïne, fenobarbital, st Johns Wort, rifampicine)
- •17. Use of serotonergic drugs (eg, trazodon, fluvoxamine)
- •18. Use of testosterone therapy within 6 months before study entry
- •19. Use of any other medication that interferes with study medication (eg, monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (eg, diltiazem and verapamil), use of corticosteroids);Drug/food interaction
- •20. Consumption of grapefruit or grapefruit-containing foods throughout the duration of the study;General
- •21. Illiteracy, unwillingness, or inability to follow study procedures
- •22. Any other clinically significant abnormality or condition which, in the opinion of investigator, might interfere with the participant*s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for buspirone and/or testosterone use.
- •23. Participation in any other clinical drug study in the previous 3 months.
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