Phase I Pharmacokinetic Pilot Study to Investigate the Bioavailability and Tolerability of Three Different Oral Formulations of Sodium Thiosulfate
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
研究概览
简要总结
Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal calculi could be a future indication for sodium thiosulfate (STS). Using an oral formulation might increase the compliance and treatment success compared to parenteral administration.
Three gastro-resistant formulations of STS for oral administration were developed with different release characteristics: fast-release, medium-release and slow-release tablets. Aim of the enteric coating was to increase the oral bioavailability of STS. The bioavailability and tolerability of these formulations for oral administration in healthy volunteers will be compared in this clinical trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy subjects ≥ 18 years
- •Negative pregnancy test in female subjects of childbearing age
- •Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
排除标准
- •Pregnant or lactating subjects.
- •Renal impairment (creatinine clearance <60ml/min)
- •Concomitant medication
- •Gastrointestinal diseases
- •History of alcohol abuse, illicit drug use, significant mental illness, physical dependance to opioid, other drug abuse or addiction (last 12 months)
研究组 & 干预措施
Fast first
Sodium thiosulfate fast release formulation first, followed by medium and slow
干预措施: Sodium thiosulfate (Drug)
Medium first
Sodium thiosulfate medium release formulation first, followed by slow and fast
干预措施: Sodium thiosulfate (Drug)
Slow first
Sodium thiosulfate slow release formulation first, followed by fast and medium
干预措施: Sodium thiosulfate (Drug)
结局指标
主要结局
Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
时间窗: 7 weeks
次要结局
- TS excretion in urine(48 hours)
- Sulfate excretion in urine: fraction of administered TS(48 hours)
- Number of participants with treatment-related adverse events(7 weeks)
- Sulfate excretion in urine: amount(48 hours)
- TS excretion in urine: amount(48 hours)
- TS excretion in urine: fraction of administered TS(48 hours)