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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
oral administration of thiosulfate
Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
Time frame: 7 weeks
Number of participants with treatment-related adverse events
Time frame: 7 weeks
TS excretion in urine
amount excreted within 48h and fraction (amount/dose) of administered thiosulfate
Time frame: 48 hours
TS excretion in urine: amount
amount excreted within 48h
Time frame: 48 hours
TS excretion in urine: fraction of administered TS
excreted / administered
Time frame: 48 hours
Sulfate excretion in urine: amount
amount excreted within 48h
Time frame: 48 hours
Sulfate excretion in urine: fraction of administered TS
excreted / administered
Time frame: 48 hours
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