NL-OMON36048已完成不适用
A phase I open-label, balanced, randomized, crossover, three-groups, three-treatments, three-period, pharmacokinetic study of intranasal testosterone gel administration to healthy, adult, male subjects - Comparison of three intranasal testosterone gel formulations
Trimel BioPharma SR0 个研究点目标入组 15 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
- 15
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. Healthy male human subjects within the age range of 18 to 45 years inclusive
- •2. Willingness to provide written informed consent to participate in the study
- •3. Body-mass index less than 30 kg/m2
- •4. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during screening
- •5. Normal otorhinolaryngological examination
- •6. Non-smokers for at least six months
- •7. Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol
排除标准
- •1. Personal / family history of allergy or hypersensitivity to testosterone or related drugs
- •2. Past history of anaphylaxis or angioedema
- •3. Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- •4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
- •5. Hemoglobin < 13g/dl and Hematocrit > 52% during screening
- •6. Any cardiac, renal or liver impairment, any other organ or system impairment
- •7. History of seizure or clinically significant psychiatric disorders
- •8. Presence of disease markers for HIV 1 and/or 2, Hepatitis B and/or C virus
- •9. History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, (*nose job*), or sinus surgery
- •10. Subject with prior nasal fractures
- •11. Subject with active allergies, such as rhinitis, rhinorrhea, or nasal congestion
- •12. Subject with mucosal inflammatory disorders, specifically pemphigus, or Sjogren*s syndrome
- •13. Subject with sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis
- •14. History of nasal disorders (e.g. polyposis, recurrent epistaxis (> 1 nose bleed per month), abuse of nasal decongestants or sleep apnea
- •15. Subject using any form of intranasal medication delivery, specifically nasal corticosteroids and oxymetazoline containing nasal sprays (e.g. Dristan 12-Hour Nasal Spray)
- •16. History of asthma and/ or on-going asthma treatment
- •17. Regular drinkers of more than three (3) units of alcohol daily (1 unit = 300 ml beer, 1 glass wine, 1 measure spirit), or consumption of alcohol within 48 hours prior to dosing and during the study.
- •18. Volunteer demonstrating a positive test for alcohol consumption (using breath alcohol analyzer) at the time of check-in during the admission periods.
- •19. History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
- •20. Volunteers demonstrating a positive test for drugs of abuse in urine (Opiates, Benzodiazepines, Amphetamines, THC and cocaine) at the time of check-in during admission periods
- •21. Inaccessibility of veins in left and right arm
- •22. Receipt of any prescription drug therapy within four weeks of the first admission period.
- •23. Difficulty in abstaining from OTC medication (except occasional paracetamol/aspirin) for the duration of the study
- •24. Volunteers demonstrating serum PSA >= 4ng/ml
- •25. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
- •26. Blood donation (usually 550 ml) at any time during this study, or within the 12 week period before the start of this study.
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