Overview

Drug Interaction Study of Pyronaridine-artesunate and Metoprolol and Pyronaridine-artesunate Re-dosing Study in Healthy Volunteers

Status:
Completed

Trial end date:
2012-10-01

Target enrollment:

Participant gender:

Summary

Pyronaridine: artesunate (Pyramax) is an antimalarial fixed-dose combination therapy which has been demonstrated to be well tolerated and effective treatment in patients with Plasmodium falciparum and vivax malaria. This open-label Phase I study has two parts: a drug-drug interaction part intended to investigate the interaction of Pyramax in the pharmacokinetics of the CYP2D6 probe metoprolol and a re-dosing evaluation part intended to investigate the differences on the changes in liver enzymes induced by Pyramax in a first and in a second treatment course and the effect of the redosing interval on the changes in liver enzymes induced by Pyramax in a first and in a second treatment course.

Phase:

Phase 1

Details

Lead Sponsor:

Medicines for Malaria Venture

Collaborator:

Shin Poong Pharmaceuticals

Treatments:

Artemisinins
Artesunate
Metoprolol
Pyronaridine