Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

May 31, 2014

Study Completion Date

September 30, 2014

Conditions
Chagas Disease
Interventions
DRUG

Nifurtimox (BAYa2502) (4 x 30 mg tablet)

120 mg single dose as four 30 mg tablets after a high fat, high calorie meal

DRUG

Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water)

120 mg single dose as aqueous slurry in tap water produced from four 30 mg tablets; ingestion after a high fat, high calorie meal

DRUG

Nifurtimox (BAYa2502) (120 mg tablet)

120 mg single dose as one 120 mg tablet after a high fat, high calorie meal

Trial Locations (1)

C1425BAB

Buenos Aires

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01927224 - Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients | Biotech Hunter | Biotech Hunter