NCT03270553已完成1 期
A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy 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
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of metformin in plasma
研究概览
简要总结
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings
排除标准
- •Estimated creatinine clearance <90 mL/min
- •Use of tobacco- or nicotine-containing products
- •History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
- •History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
- •History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
研究组 & 干预措施
Sequence 1
Experimental
In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
干预措施: plazomicin (Drug)
Sequence 1
Experimental
In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
干预措施: metformin (Drug)
Sequence 2
Experimental
In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
干预措施: plazomicin (Drug)
Sequence 2
Experimental
In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
干预措施: metformin (Drug)
结局指标
主要结局
Pharmacokinetics of metformin in plasma
时间窗: 9 days
次要结局
- Incidence and severity of adverse events(15 days)
- Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)(8 days)
- Pharmacokinetics of plazomicin in plasma(9 days)
- Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)(9 days)
- Pharmacokinetics of metformin in urine(9 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 TabletsHealthyNCT02373046Lexicon Pharmaceuticals30
已完成
1 期
Bioavailability of Levoketoconazole and Ketoconazole TabletsHealthyNCT04212000Cortendo AB34
已完成
1 期
Levoketoconazole Food Effect Study in Healthy SubjectsHealthy SubjectsNCT03768388Cortendo AB22
已完成
1 期
A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and RosuvastatinHypertensionHyperlipidemiaNCT02951962Yuhan Corporation60
已完成
1 期
Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic MalignanciesHematological NeoplasmsNon-Hodgkin's LymphomaHodgkin's LymphomaMyelodysplastic SyndromesNeoplasmsMultiple MyelomaLymphomaLeukemiaMelanomaOsteosarcomaGenitourinaryBreast CancerNon-Small Cell Lung CancerMetastatic Breast CancerSarcomaRenal Cell CarcinomaAcute Myeloid LeukemiaSmall Cell Lung CancerThyroid CancerGlioblastoma MultiformeNCT02223052Celgene89