ISRCTN19708972已完成不适用
Dose response, pharmacodynamic and pharmacokinetic study of P-3074, a new finasteride 0.25% topical solution, after 7-day multiple dose administration in male volunteers with androgenetic alopecia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
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
- 性别
- Male
入选标准
- •To be enrolled in this study, subjects must fulfil all of these criteria:
- •1. Informed consent: signed written informed consent before inclusion in the study
- •2. Sex and age: males, 18-65 years old inclusive
- •3. Androgenetic alopecia: recession of the frontal hairline and hair loss in the vertex or crown, or loss of hair over the frontal and vertex scalp regions, corresponding to at least stage 2 of the Hamilton-Norwood scale
- •4. Body mass index: 18.5-30 kg/m2 inclusive
- •5. 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 position
- •6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
排除标准
- •Subjects meeting any of these criteria will not be enrolled in the study:
- •1. ECG: clinically relevant abnormalities at ECG (12 leads)
- •2. Skin of the scalp: skin damage such as abrasion, hyperkeratosis or any abnormal findings in the scalp
- •3. Physical findings: clinically relevant abnormal physical findings
- •4. Laboratory analysis: clinically relevant abnormal laboratory values indicative of physical illness
- •5. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- •6. Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
- •7. Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study (the anaesthetic used for the biopsies will be allowed; paracetamol and oral peri-operative antibiotic prophylaxis will be administered as needed)
- •8. Investigative drug studies: participation in the evaluation of any drug for 3 months starting from the first day of the month following the last visit in a previous study
- •9. Blood donations: blood donations for 3 months before this study
- •10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>2 drinks/day, defined according to USDA Dietary Guidelines 2010), caffeine (>5 cups coffee/tea/day) or tobacco abuse (>10 cigarettes/day)
- •11. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks
- •12. Alcohol test: positive alcohol breath test before starting P-3074 administration
- •13. Drug abuse: positive abuse drug test at screening
研究者
相似试验
尚未招募
不适用
A study on the pharmacokinetics and pharmacodynamics of remimazolam during total intravenous anesthesia with remifentanilKCT0007066Inje University Busan Paik Hospital15
进行中（未招募）
不适用
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).EUCTR2013-003000-39-EEInstitut de Recherches Internationales Servier125
进行中（未招募）
不适用
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).EUCTR2013-003000-39-HUInstitut de Recherches Internationales Servier200
进行中（未招募）
不适用
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).Patients with chronic heart failure and left ventricular systolicdysfunctionMedDRA version: 17.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849EUCTR2013-003000-39-BEInstitut de Recherches Internationales Servier125
进行中（未招募）
不适用
Evaluation of the reduction in heart rate, of the quantity of drug in the plasma and of the safety after different ascending oral doses of the active substance or a placebo in heart failure patients with a reduction of left ventricular ejection fraction (i.e. thequantity of blood the heart is able to eject in the body at each heart beat).Patients with chronic heart failure and left ventricular systolicdysfunctionMedDRA version: 17.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849EUCTR2013-003000-39-SKInstitut de Recherches Internationales Servier200