NCT04421885已完成1 期
An Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover, Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax).
研究概览
简要总结
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female, 18 to 55 years of age
- •Continuous non-smoker.
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs.
- •Has suitable venous access for repeated blood sampling.
- •A female of childbearing potential must agree to abstain from sexual activity that could lead to pregnancy.
- •A female of non-childbearing potential.
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •History of significant allergic disease requiring treatment.
- •History or presence of alcoholism or drug abuse.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- •History of known genetic metabolism anomaly associated with carnitine deficiency.
- •Female subjects with a positive pregnancy test or who are lactating.
- •Positive urine drug or alcohol results.
- •Positive results for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- •QTcF interval is > 460 msec (males) or > 470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at the screening visit.
- •Estimated creatinine clearance < 80 mL/min at the screening visit.
- •Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements.
研究组 & 干预措施
A: TBPM-PI-HBr (Reference - fasted)
Experimental
600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference (Drug)
B: TBPM-PI-HBr (Test - fasted)
Experimental
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test (Drug)
C: TBPM-PI-HBr (Test - fed)
Experimental
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fed conditions.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax).
时间窗: 24h (Day 2) post dose (Arms: A, B, C)
Area under the curve extrapolated to infinity (AUC0-∞).
时间窗: 24h (Day 2) post dose (Arms: A, B, C)
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
时间窗: 24h (Day 2) post dose (Arms: A, B, C)
次要结局
- Time to the maximum plasma concentration (Tmax).(24h (Day 2) post dose (Arms: B, C))
- Maximum plasma concentration (Cmax).(24h (Day 2) post dose (Arms: B, C))
- Terminal elimination half-life (t½).(24h (Day 2) post dose (Arms: B, C))
- Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).(24h (Day 2) post dose (Arms: B, C))
- Apparent total body clearance (CL/F)(24h (Day 2) post dose (Arms: B, C))
- Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.(12 to 14 days after the last dose of study drug)
- Area under the curve extrapolated to infinity (AUC0-∞).(24h (Day 2) post dose (Arms: B, C))
- Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).(24h (Day 2) post dose (Arms: B, C))
研究者
研究点 (1)
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