A Study on the Relative Bioavailability of HR19042 Capsules in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax: Maximum plasma concentration. Blood samples will be collected.
研究概览
简要总结
This is a single-center, randomized, open-label, three-period, dual Latin square crossover study.
Primary Objective：
- To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®).
Secondary Objective 2. To assess safety following administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
- •Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
- •Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.
排除标准
- •Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
- •Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
- •Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
- •History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
- •Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
- •Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
- •Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
- •Difficulty in venous blood sampling or fear of needles/blood.
- •Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.
研究组 & 干预措施
Sequence 1
Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk®
干预措施: HR19042 Capsule, Tarpeyo®, Budenofalk® (Drug)
Sequence 2
Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules
干预措施: HR19042 Capsule, Tarpeyo®, Budenofalk® (Drug)
Sequence 3
Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo®
干预措施: HR19042 Capsule, Tarpeyo®, Budenofalk® (Drug)
Sequence 4
Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk®
干预措施: HR19042 Capsule, Tarpeyo®, Budenofalk® (Drug)
Sequence 5
Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo®
干预措施: HR19042 Capsule, Tarpeyo®, Budenofalk® (Drug)
Sequence 6
Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules
干预措施: HR19042 Capsule, Tarpeyo®, Budenofalk® (Drug)
结局指标
主要结局
Cmax: Maximum plasma concentration. Blood samples will be collected.
时间窗: From Day 1 up to Day 8
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
时间窗: From Day 1 up to Day 8
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
时间窗: From Day 1 up to Day 8
Tmax: Observed time to reach Cmax. Blood samples will be collected.
时间窗: From Day 1 up to Day 8
次要结局
- Incidence of treatment emergent AEs (TEAEs)(From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14))