NCT07472361已完成1 期
A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ENX-104 Administered Orally as a Solution Fasted, a Tablet Fasted, or a Tablet With a High Fat Meal in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma Concentration of ENX-104
研究概览
简要总结
The study is designed to evaluate the relative bioavailability, safety, and tolerability of a single dose of ENX-104 administered orally as a solution fasted, a tablet fasted, or a tablet with a high fat meal in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Biologically female participants (defined as assigned female at birth): a) Of non-childbearing potential, (Note: For female participants with Follicle-Stimulating Hormone [FSH] levels that are not consistent with postmenopausal status, enrollment will be at the Investigator's discretion and will require a negative pregnancy test Screening and Admission [Day -1]); b) Of childbearing potential and willing to use highly effective methods of contraception, from Screening until 180 days after the last exposure to study drug, and with a negative pregnancy test at Screening and Admission (Day -1); c) Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
- •Biologically male participants (defined as assigned male at birth), if fertile, must be willing to use highly effective contraception, from first Screening through to 3 months after the last dose of study drug
排除标准
- •Is unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study
研究组 & 干预措施
Treatment 3
Experimental
干预措施: ENX-104 (Drug)
Treatment 1
Experimental
干预措施: ENX-104 (Drug)
Treatment 2
Experimental
干预措施: ENX-104 (Drug)
结局指标
主要结局
Plasma Concentration of ENX-104
时间窗: Up to Day 16
次要结局
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to Day 22)
- Plasma Concentration of Metabolites of ENX-1014(Up to Day 16)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A clinical study on bioavailability of FBQP-AK-24 in Healthy Human Volunteers.CTRI/2025/02/081268Akay Natural Ingredients Pvt. Ltd15
尚未招募
不适用
Abuse Liability for Eight Electronic Nicotine ProductsNCT07323511RAI Services Company70
尚未招募
不适用
A bioavailability study to compare two Berberine formulations with two Berberine + Turmeric formulations in healthy adult human subjects.CTRI/2024/06/069426Himalaya Wellness Company24
尚未招募
不适用
A study to find out how MB EnzymePro® Capsule affects the absorption of whey protein in healthy adult men under fasting conditions.CTRI/2025/11/097046Bright Lifecare Pvt. Ltd. (Healthkart)84
已完成
4 期
Single Dose Crossover Comparative Bioavailability and Food Effect Study of Celecoxib 10 mg/1 mL Oral Suspension versus Celebrex®️ (celecoxib) 200 mg Capsules Following the Administration of a 200 mg Dose in Healthy Adult Volunteers / Fasting and Fed State.2023-504052-99-00Codadose Inc.54