A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)-Budesonide
研究概览
简要总结
Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
详细描述
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
- •Male and female subjects 18 to 40 years of age, inclusive
- •Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
- •Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
- •Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period
- •Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.
- •Demonstrate correct MDI administration technique
排除标准
- •For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
- •Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- •Subjects who have cancer that has not been in complete remission for at least 5 years
- •Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
- •Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
- •History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening
- •History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting
- •A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period
- •Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use
- •Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period
- •Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
- •Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
研究组 & 干预措施
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen A (Drug)
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen B (Drug)
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen C (Drug)
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen D (Drug)
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen A (Drug)
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen B (Drug)
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen C (Drug)
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen D (Drug)
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen A (Drug)
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen B (Drug)
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen C (Drug)
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen D (Drug)
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen A (Drug)
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen B (Drug)
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen C (Drug)
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
干预措施: Regimen D (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)-Budesonide
时间窗: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Maximum Plasma Concentration (Cmax)-Formoterol
时间窗: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
时间窗: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Maximum Plasma Concentration (Cmax)-Glycopyrronium
时间窗: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
时间窗: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
时间窗: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
次要结局
- Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Time to Maximum Plasma Concentration (Tmax)-Budesonide(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol(24 hrs)
- Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Time to Maximum Plasma Concentration (Tmax)-Formoterol(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)