An Open-Label, 3-Period, Fixed-Sequence, Study to Examine the Effect of Aluminum Hydroxide/Magnesium Hydroxide/Simethicone and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
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
- Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t).
研究概览
简要总结
To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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, 18-55 years of age, inclusive, at the screening visit.
- •Continuous non-smoker
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
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 in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, 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 within the past 2 years prior to the first dose.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).
- •History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia).
- •History of cholecystectomy.
- •Female subjects with a positive pregnancy test at the screening visit or first check-in or who are lactating.
- •Positive urine drug or alcohol results at the screening visit or first check-in.
- •Positive results at the screening visit for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
研究组 & 干预措施
TBPM-PI-HBr Alone (Period 1)
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally alone.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) (Drug)
TBPM-PI-HBr and Antacid (Period 2)
20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension will be coadministered with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr at Hour 0 on Day 1.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) (Drug)
TBPM-PI-HBr and Antacid (Period 2)
20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension will be coadministered with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr at Hour 0 on Day 1.
干预措施: 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) (Drug)
TBPM-PI-HBr and Omeprazole (Period 3)
40 mg (1 x 40 mg capsule) omeprazole administered QD at Hour -2 on Days 1 through 5, with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr administered at Hour 0 on Day 5.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) (Drug)
TBPM-PI-HBr and Omeprazole (Period 3)
40 mg (1 x 40 mg capsule) omeprazole administered QD at Hour -2 on Days 1 through 5, with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr administered at Hour 0 on Day 5.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t).
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Area under the curve extrapolated to infinity (AUC0-∞).
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent total body clearance (CL/F)
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Percent of AUC0-inf extrapolated (AUC%extrap)
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Maximum plasma concentration (Cmax).
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Time to the maximum plasma concentration (Tmax).
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Terminal elimination half-life (t½).
时间窗: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
次要结局
- 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)