Pharmacokinetics of Micronized Artemisinin in Healthy Vietnamese Males
Author Information
Author(s): Hien Tran Tinh, Hanpithakpong Warunee, Truong Nguyen Thanh, Dung Nguyen Thi, Toi Pham Van, Farrar Jeremy, Lindegardh Niklas, Tarning Joel, Ashton Michael
Primary Institution: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Hypothesis
Micronization of artemisinin powder will increase its oral bioavailability.
Conclusion
The study found that the new micronized formulation of artemisinin resulted in higher drug exposure compared to the standard formulation, but the difference was small and likely not clinically significant.
Supporting Evidence
- Pharmacokinetic parameters showed higher values for the new formulation compared to the standard formulation.
- All formulations were well tolerated with no adverse events reported.
- Bioequivalence could not be assumed as the 90% CIs extended beyond the FDA's stipulated limits.
Takeaway
This study tested a new form of artemisinin to see if it works better in the body. It found that while the new form is a bit better, it's not enough to make a big difference in treating malaria.
Methodology
A single-center, randomized, 4-sequence, open-label, crossover study with 15 healthy male volunteers receiving different formulations of artemisinin.
Limitations
The study was conducted in a small sample of healthy males, which may not represent the general population or patients with malaria.
Participant Demographics
Healthy Vietnamese male volunteers aged 18 to 55 years.
Statistical Information
P-Value
p=0.151 for Cmax, p=0.052 for AUC0–last, p=0.086 for AUC0–∞
Confidence Interval
90% CI for Cmax, AUC0–last, and AUC0–∞ were 92.5–158, 101–148, and 98.0–146 respectively.
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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