Comparative study of @entity8185 and XXXX safety in healthy Thai volunteers.

@entity137 @entity8185 @entity4601 @entity507 @entity506 @entity236
OBJECTIVE: As part of new drug development initiatives in Thailand, a new tablet formulation of @entity8185 ( @entity4601 , an antimalarial drug) has been developed. Our previous bioequivalence study indicated that the new and reference @entity4601 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. @entity506 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 ( @entity4601 : 0.48 g/dl, p = 0.007; artesunate 0.38 g/dl, p = 0.001). Transient @entity236 was evidenced by reduction of reticulocytes with a lowest number on study Day 5 (artesunate 75% reduction in reticulocyte count; @entity4601 47%, p < 0.001 for both drugs compared to baseline). CONCLUSION: The present study confirmed our previous finding on significant decrease in hemoglobin. Artesunate appeared to have more negative effects on the numbers of reticulocytes and white blood cells than @entity4601 . Systemic laboratory and @entity137 profiles presented in this study may be used as a framework for future clinical studies of @entity507 and its derivatives.
