Phase I Pharmacokinetic Pilot Study to Investigate the Bioavailability and Tolerability of Three Different Oral Formulations of Sodium Thiosulfate

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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.

2018-12-01

2019-05-01

2019-12-01

Withdrawn

Early phase I

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-02-09