drugset / Trial / NCT00538382
Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo
Phase 1
Completed
51 enrolled
NICHD Global Network for Women's and Children's Health
Bill and Melinda Gates Foundation · collabFogarty International Center of the National Institute of Health · collabGlobal Network for Women's and Children's Health Research · collabKinshasa School of Public Health · collabNational Cancer Institute (NCI) · collabNational Center for Complementary and Integrative Health (NCCIH) · collabNational Institute of Dental and Craniofacial Research (NIDCR) · collabRTI International · collabUniversity of North Carolina · collab
Non-randomizedSingle-groupOpen-label
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.
Timeline
- Start
- 2007-05
- Primary completion
- 2008-11
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 200 mg | Oral |