drugset / Trial / NCT02493283

Pharmacokinetics and Distribution of Dapsone in Leucocytes After Single-dose and Multiple-dose Administration

NCT02493283

Phase 1 Completed 23 enrolled University Medicine Greifswald
Non-randomizedSingle-groupOpen-labelBasic science

Summary

The objectives of the study are * to evaluate pharmacokinetics, distribution in blood leucocytes, metabolism and methemoglobinemia after single-dose and repeated-dose administration of 100 mg of dapsone in healthy subjects genotyped for CYP2C9 and NAT2 * to evaluate serum through levels, distribution in blood leucocytes and methemoglobinemia after repeated-dose treatment with dapsone in patients with autoimmune bullous dermatoses before and after concomitant treatment with glucocorticoids

Timeline

Start
2011-09
Primary completion
2012-06
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapsone Small molecule 100 mg Oral