NL-OMON49790已完成不适用
on-blinded, non-randomized study to investigate the pharmacokinetics, including absolute bioavailability of BAY 2433334 following administration of a 25 mg oral dose and a 50 µg intravenous [13C7,15N]-labeled BAY 2433334 microdose in healthy male participants - PK and absolute bioavailability of BAY 2433334
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 16
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
- •healthy white male
- •18 to 45 years old at the time of the screening visit
- •BMI is between 18 and 29.9 kilograms/meter2
- •not regularly drink more than 17.5 units of alcohol per week. 17.5 units of
- •alcohol is equal to approximately 12 glasses (285 mL) of beer or lager, 12
- •glasses (125 mL) of wine, or 17 small shots (25 mL) of spirits.
- •do not regularly consume more than 1 L of methylxanthine or
- •caffeine-containing beverages daily.
- •did not donate more than 100 mL of blood or plasma within 4 weeks or 500 mL
- •blood within 3 months before study compound administration. Blood donation is
- •not allowed during the entire study, until 3 months after the last visit.
- •not participated in any other drug study within 3 months preceding the
- •administration of the study compound.
- •no history of COVID-19 infection, do not test positive in the SARS-CoV-2
- •test, and no contact with SARS-CoV-2-positive or COVID-19 patients within 4
- •weeks prior to admission to the research center.
- •at screening the state of health must satisfy the study entry requirements.
排除标准
- •1. A history of relevant diseases of vital organs, of the central nervous
- •system or other
- •2. Medical disorder, condition or history of such that would impair the
- •participant*s ability to participate or complete this study in the opinion of
- •the investigator.
- •3. Incompletely cured pre-existing diseases for which it can be assumed that
- •the absorption, distribution, metabolism, elimination and effects of the study
- •intervention will not be normal.
- •4. Known hypersensitivity to the study interventions (active substance or
- •excipients of
- •the preparation).
- •5. Known severe allergies e.g. allergies to more than 3 allergens, allergies
- •affecting the
- •lower respiratory tract - allergic asthma, allergies requiring therapy with
- •corticosteroids, urticaria or significant non-allergic drug reactions.
研究者
相似试验
进行中（未招募）
1 期
ASC-201 Plus Trifluridine/Tipiracil for the Treatment of Advanced Gastric CancerAdvanced Gastric Cancer.MedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-003799-15-ESAscelia Pharma AB139
进行中（未招募）
不适用
Study to evaluate The Efficacy, Safety And Pharmacokinetics Of Legalon® Sil, Alone Or In Combination With Ribavirin, For The Prevention Of Recurrent Hepatitis C In Liver Transplant RecipientsEUCTR2012-000281-38-ESRottapharm156
尚未招募
Unknown
se of night-time postural care with online caregiver support for children with severe cerebral palsy and its effect of preventing postural deformitiesCerebral palsy Children with profound intellectual and multiple disabilitiesJPRN-UMIN000050459Kansai Medical University20
进行中（未招募）
1 期
Effect of testosterone in male patients on regular hemodialysisHypogonadal males undergoing hemodialysis (HD).EUCTR2011-005439-20-SEDept of Renal medicine40
招募中
4 期
Performance and safety evaluation of pelvic plate system fixation during fractures, fusions, andosteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac jointCTRI/2023/06/053602Auxein Medical Pvt. Ltd