Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)
of a standard dose of orally administered artesunate, in order to determine if the current
adult dose (200 mg) is appropriate in parasitemic pregnant women when compared to the same
women at three months postpartum and to parasitemic non-pregnant women. Preliminary evidence
on safety, tolerability and efficacy will be gathered.
Phase:
Phase 1
Details
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborators:
Bill and Melinda Gates Foundation Fogarty International Center of the National Institute of Health Global Network for Women's and Children's Health Research John E. Fogarty International Center (FIC) Kinshasa School of Public Health National Cancer Institute (NCI) National Center for Complementary and Integrative Health (NCCIH) National Institute of Dental and Craniofacial Research (NIDCR) RTI International University of North Carolina