Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

October 31, 2012

Conditions
Malaria
Interventions
DRUG

Metoprolol and pyronaridine-artesunate

"On Day 1, subjects will receive a single oral 100 mg dose of metoprolol tartrate. On Day 8 and Day 9, subjects will receive a once daily oral dose of pyronaridine-artesunate as follows:~55 - \< 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate)~≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate)~On Day 10, a 100 mg dose of metoprolol will be coadministered with pyronaridine-artesunate at the above dose.~On Days 98 - 100, subjects will receive pyronaridine-artesunate once daily at the same dose described above. Followed by a 40 day follow-up period."

DRUG

pyronaridine-artesunate

"On Days 1 to 3, subjects will receive 3 days of pyronaridine-artesunate as follows:~55 - \< 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate)~≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate)~On Days 61 to 63, subjects will be redosed with a 3 day course of pyronaridine-artesunate at the above dose.~Followed by a 40 day follow-up period."

Trial Locations (1)

4123

Covance Clinical Research Unit AG, Allschwil

All Listed Sponsors
collaborator

Shin Poong Pharmaceuticals

INDUSTRY

lead

Medicines for Malaria Venture

OTHER

NCT01523002 - Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate | Biotech Hunter | Biotech Hunter