1. Comparative study of dihydroartemisinin and artesunate safety in healthy Thai volunteers
- Author
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Supornchai Kongpatanakul, Somruedee Chatsiricharoenkul, Jaranit Kaewkungwal, S Atipas, and A Khuhapinant
- Subjects
Adult ,Male ,Reticulocytes ,medicine.medical_treatment ,Dihydroartemisinin ,Artesunate ,Pharmacology ,law.invention ,chemistry.chemical_compound ,Antimalarials ,Hemoglobins ,Leukocyte Count ,Young Adult ,Randomized controlled trial ,law ,Bone Marrow ,Medicine ,Humans ,Pharmacology (medical) ,Single-Blind Method ,Artemisinin ,Adverse effect ,Cross-Over Studies ,business.industry ,Thailand ,Crossover study ,Artemisinins ,Blood Cell Count ,chemistry ,Bone marrow suppression ,Toxicity ,Female ,business ,medicine.drug - Abstract
Objective: As part of new drug development initiatives in Thailand, a new tablet formulation of dihydroartemisinin (DHA, an antimalarial drug) has been developed. Our previous bioequivalence study indicated that the new and reference DHA formulations were well tolerated; however, a significant decrease in hemoglobin was detected after a single 200-mg oral dose. To explore further, a clinical study with an emphasis on hematological parameters was conducted. Methods: A single-center, randomized, single-blind, cross-over clinical study was conducted in 18 healthy volunteers with a dosage of 300 mg daily for 2 days. Artesunate was used as a comparator. Adverse events were monitored and laboratory parameters on study Days 0, 2, 5, and 7 post drug administrations were analyzed. Results: Eighteen volunteers completed both rounds of the study. Both drugs were well tolerated. All adverse events were mild. Significant decrease in hemoglobin compared to baseline was detected for both drugs 7 days after administration (DHA: 0.48 g/dl, p = 0.007; artesunate 0.38 g/dl, p = 0.001). Transient bone marrow suppression was evidenced by reduction of reticulocytes with a lowest number on study Day 5 (artesunate 75% reduction in reticulocyte count; DHA 47%, p
- Published
- 2009