NL-OMON49936已完成不适用
A randomized, open-label, single dose two-way cross-over pharmacokinetic study of 3D-printed sildenafil tablets compared to the originator sildenafil tablets in healthy adults - Pharmacokinetic study of 3D-printed sildenafil tablets in healthy adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 64（—）
入选标准
- •1. Healthy volunteers (male) as determined by medical history, clinical
- •laboratory tests and physical examination.
- •* Vital signs (systolic blood pressure 100-139 mmHg, diastolic blood pressure
- •50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting
- •* Clinical laboratory test (biochemistry and haematology blood tests and
- •urinalysis) results within normal reference range for the investigative site,
- •or results with acceptable deviations that are judged to be not clinically
- •significant by the investigator.
- •2. >= 18 and <= 55 years of age
- •3. Body weight >50 kg and Body Mass Index (BMI) between 18.5 and 30 kg/m2
- •4. Written informed consent
- •5. The ability to fully comprehend the nature and aims of the study, including
- •possible risks and side effects.
排除标准
- •1. Contraindication for sildenafil:
- •* loss of vision in one eye because of non-arteritic anterior ischaemic optic
- •neuropathy (NAION) or known hereditary degenerative retinal disorders
- •* sickle cell anemia
- •* severe hepatic impairment (Child-Pugh C)
- •* hypotension (blood pressure <90/50 mmHg)
- •* recent history of stroke or myocardial infarction (last six months)
- •2. Anatomical deformation of the penis (such as angulation, cavernosal fibrosis
- •or Peyronie*s disease)
- •3. History or presence of clinically significant disease (e.g. multiple
- •myeloma, leukaemia, bleeding disorders or active peptic ulceration)
- •4. Clinically significant cardiac abnormalities assessed by electrocardiography
- •5. Clinically significant abnormal physical findings
- •6. Clinically significant abnormal laboratory values indicative of physical
- •illness (including hepatic and renal panels, complete blood count, chemistry
- •panel and urinalysis).
- •7. Positive screening test for Hepatitis B, Hepatitis C or human
- •immunodeficiency virus (HIV))
- •8. Galactose intolerance
- •9. Hypersensitivity to the active substance and/or any of the excipients of the
- •formulations or a history of anaphylaxis to drugs or allergic reactions in
- •10. Participation in the evaluation of any investigational product or donation
- •of blood for 3 months before this study
- •11. History of alcohol or drug abuse within the last year
- •12. Use of prescription medications within 14 days of study drug administration
- •or over-the-counter (OTC) medications, herbal supplements, or multivitamins
- •within 7 days, or drugs that are known to be strong or moderate inhibitors or
- •inducers of CYP3A4 and CYP2C9 within 30 days of study drug administration or
- •less than 5 half-lives (whichever is longer), with the exception of paracetamol
- •(up to 4 gram/day).
- •13. Positive test for drugs of abuse at screening or pre-dose
- •14. Unable to abstain from use of tobacco or nicotine containing products
- •during the trial period
研究者
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