NCT02624479

Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sodium thiosulfate	oral administration of thiosulfate

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-05-01
• Completion: 2019-12-01
• First posted: 2015-12-08
• Last updated: 2023-02-09