An Open-Label, Single-Center, Single-Period Study to Compare Two Bioanalytical Assays for Tebipenem Following Administration of Oral Tebipenem Pivoxil Hydrobromide in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Tebipenem (TBP) Samples With Converted (From Whole Blood Measurements) and Measured Plasma Concentrations That Have a Difference not Exceeding ±20% of the Mean of the Concentrations
研究概览
简要总结
The primary purpose of the study is to compare the concentrations of tebipenem (TBP), the active moiety of tebipenem pivoxil hydrobromide (TBP-PI-HBr), as determined by two bioanalytical assays, a whole blood assay and a plasma assay, following a single oral dose of TBP-PI-HBr 600 milligram (mg) tablets in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) at Screening visit.
- •Medically healthy with no clinically significant medical history, abnormalities in physical examination, laboratory variables, vital signs or electrocardiogram (ECG) at the time of Screening visit and Check-in (Day-1), as deemed by the investigator or designee.
- •Have suitable venous access for repeated blood sampling.
排除标准
- •Any clinically significant medical history or observations at the time of Screening visit or Check-in (Day -1) not specifically excluded in other criteria that, in the opinion of the investigator or designee, may confound the results of the study, compromise the safety of the participant or otherwise render the participant unsuitable for participation.
- •Use/receipt of any prescription or non-prescription medication, herbal products, vitamins or vaccines within 14 days (or 5 half-lives whichever is longer) prior to Check-in (Day -1).
- •Positive coronavirus disease (COVID-19) screening test using polymerase chain reaction (PCR) or antigen assay at Screening visit or Check-in (Day -1).
- •Donation or significant blood loss of more than 500 milliliter (mL) of blood within 56 days prior to enrollment, or receipt of a blood transfusion within 1 year prior to enrollment; plasma donation within 7 days prior to dosing.
- •ECG with corrected QT interval by Fridericia (QTcF) interval duration equal or greater than 450 milliseconds (msec) for males and 470 msec for females obtained after at least 5 minutes in a supine or semi-recumbent position at quiet rest at Screening visit or Check-in (Day -1).
- •Other inclusion and exclusion criteria as per protocol may apply.
研究组 & 干预措施
TBP-PI-HBr 600 mg
Healthy participants meeting eligibility criteria will receive a single oral dose of TBP-PI-HBr 600 mg tablets (2 x 300 mg) on Day 1 under fasted conditions.
干预措施: TBP-PI-HBr (Drug)
结局指标
主要结局
Percentage of Tebipenem (TBP) Samples With Converted (From Whole Blood Measurements) and Measured Plasma Concentrations That Have a Difference not Exceeding ±20% of the Mean of the Concentrations
时间窗: Pre dose and at multiple time points post dose on Day 1
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-∞) of TBP
时间窗: Pre dose and at multiple time points post dose on Day 1
Maximum Plasma Concentration (Cmax) of TBP
时间窗: Pre dose and at multiple time points post dose on Day 1
次要结局
- Number of Participants With Adverse Events (AEs)(From first dose of study drug up to Day 6)