A Phase I，Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
详细描述
The test group was completed in sequence from low to high concentrations, and safety tolerance was assessed after administration in one concentration group to determine whether to conduct follow-up group studies and, if necessary, adjust sampling time points according to pre-experimental results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age is 18-65 years old. Men and women are not restricted.
- •Clinical diagnosis of simple chronic suppurative otitis media with ear effusion secretion, tympanic membrane perforation about 2 mm, the need for local use of antibiotics in patients.
- •Voluntarily sign written informed consent.
- •Non-breast-feeding women volunteered to take appropriate contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) during the study period (screening period to one week after administration). Men are willing to use approved contraceptive methods (including the use of condoms and spermicides or the use of oral, implantable or injectable contraceptives by their partners, intrauterine devices, diaphragms and spermicides) or sexual partner infertility.
排除标准
- •Quinolone antibiotics allergy and severe allergic constitution.
- •During the study, ear fluid could not be collected.
- •Patients with severe need for systemic use of antibiotics.
- •Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
- •Patients with cholesteatoma.
- •Complicated with symptoms of extraaural infection (such as periaural cellulitis, mumps) or intracranial and extracranial complications (such as meningitis, brain abscess, thrombophlebitis of sigmoid sinus, subperiosteal abscess of the ear, Bezold's abscess of the neck).
- •Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
- •People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.
- •Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate < 60ml/min).
- •Use any local or systemic antibiotics in the first 3 days of the admission.
- •Use any quinolones within the first 7 days of admission.
- •There were smokers who smoked more than 5 cigarettes a day within one year.
- •There was a history of alcoholism and drug abuse within one year.
- •Diagnosis of diabetes or poor blood glucose control.
- •Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
- •Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
- •Patients who took part in other clinical trials in the first 3 months.
- •Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
- •Researchers believe that patients who are not fit to participate in this clinical trial.
研究组 & 干预措施
0.1% single-dose pre
Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
干预措施: Pazufloxacin Mesilate ear drops (Drug)
0.1% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose
干预措施: Pazufloxacin Mesilate ear drops (Drug)
0.3% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose
干预措施: Pazufloxacin Mesilate ear drops (Drug)
0.5% single-dose
Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose
干预措施: Pazufloxacin Mesilate ear drops (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Within two days after administration
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
次要结局
- Cmax(Within two days after administration)
- Tmax(Within two days after administration)
- Area under concentration time curve(Within two days after administration)