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

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

March 31, 2015

Conditions
MethemoglobinemiaLinear IgA Bullous Dermatosis
Interventions
DRUG

Dapsone single dose

Administration of two tablets Dapson-Fatol 50 mg Tabletten (= 100 mg dapsone) and sampling of blood (before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after single-dose administration), urine (0-24 h, 24-48 h, 48-72 h, 72-96 h, 96 -120 h) and feces (on treatment days 1-5)

DRUG

Dapsone multiple dose

Administration of two tablets Dapson-Fatol 50 mg Tabletten (= 100 mg dapsone) s.i.d. for 7 days and sampling of blood (before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after last repeated-dose administration), urine (last treatment day 0-24 h) and feces (on treatment days 12-15)

BIOLOGICAL

leucocytes

sampling for leucocytes collection: study days -1, 1, 14 and 15

BIOLOGICAL

Met-Hb

sampling before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after single-dose administration, before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after last repeated-dose administration and sampling for additional safety analyses (Met-Hb): study days 10, 12, 14 and hematology on study day 12

Trial Locations (1)

17487

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald, Greifswald

All Listed Sponsors
lead

University Medicine Greifswald

OTHER

NCT02493283 - Pharmacokinetics and Distribution of Dapsone in Leucocytes After Single-dose and Multiple-dose Administration | Biotech Hunter | Biotech Hunter