JPRN-jRCT2080225113招募中1 期
An Open-label Parallel-Group Study to Evaluate Pharmacokinetics of E7090 and its Metabolite in Subjects with Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1. BMI between 18 to 40 kg/m2.
- •2. For participants with hepatic Impairment: stable hepatic impairment conforming to Child-Pugh classification A and B.
- •3. For Healthy subjects: matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20%), race and gender.
排除标准
- •[Hepatic impairment Cohort]
- •1.Any significant acute medical illness, such as new conditions or the exacerbation of pre-existing conditions, within 8 weeks of dosing.
- •2.Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy.
- •3.The subject's standard therapy/concomitant medication for diseases related to hepatic impairment has not remained stable/unchanged for at least 2 weeks prior to dosing.
- •[Healthy subject Cohort]
- •1.Subjects tested positive for syphilis (qualitative).
- •2.Any abnormal finding based on physical examination, assessment of vital signs, and ECG, or laboratory test results that requires treatment or clinical follow-up based on the investigator's opinion.
研究者
相似试验
已完成
2 期
An open label, parallel group study to explore pharmacodynamics, pharmacokinetics and safety during 3 cyclic treatments of FSN-013 (E4/DRSP) in Japanese endometriosis patientsendometriosisJPRN-jRCT2080225090Fuji Pharma Co., Ltd.80
进行中（未招募）
不适用
A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)Pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD.MedDRA version: 14.1Level: PTClassification code 10017885Term: Gastrooesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001156-19-Outside-EU/EEAAstraZeneca LP28
进行中（未招募）
不适用
A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Esomeprazole Magnesium 20 mg and 40 mg in a Pediatric Population of 12 to 17 Year-Olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERD.12- to 17-year-olds inclusive with GERD or symptoms of GERD.MedDRA version: 14.1Level: PTClassification code 10017885Term: Gastrooesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001158-25-Outside-EU/EEAAstraZeneca AB16
进行中（未招募）
不适用
A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Multiple Doses of Esomeprazole Magnesium in a Pediatric Population of 1 to 11 Year olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERDThe target subject population was male and female children, aged 1 to 11 years inclusive, who suffered from GERD or symptoms of GERD and were candidates for acid suppression therapy.MedDRA version: 14.1Level: PTClassification code 10017885Term: Gastrooesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001157-97-Outside-EU/EEAAstraZeneca AB31
进行中（未招募）
1 期
An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1Idiopathic or familial PAHEUCTR2004-005157-63-GBActelion Pharmaceuticals Ltd.33