Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers

Bioequivalence test should be carried out for copy medicine, including dihydroartemisinin-piperaquine (DHP), which is used to treat critical diseases requiring medication. To predict the bioequivalence of film coated DHP generic tablets compared to the reference, a randomized controlled trial, single blind, single dose cross over design, two sequences, 2 periods, and wash-out period 7 days was conducted on 8 healthy adults. Blood samples were taken at certain times; plasma levels of dihydroartemisinin (DHA) were determined and analyzed for pharmacokinetics profile using UPLC MS MS system. The mean ±SD of AUC(0-24), C(max), T(max), and T½ of the test drug (T) in the following order were 220.07 ± 64.48 ng.mL-1.hour; 119.00 ± 37.66 ng.mL-1.hour; 1.16 ± 0.30 hour; and 1.06 ± 0.31 hour. The mean ±SD of AUC(0-24), C(max), T(max), and T½ of the reference drug (R) were 301.91 ± 161.30 ng.mL-1.hour; 203.60 ± 91.04 ng.mL-1.hour; 0.94 ± 0.35 hour; and 0.80 ± 0.21 hour. Based on statistical analysis, the geometrics mean ratio (T/R) for the C(max) and AUC(0-t) were 0.6083 with 90% CI (0.4853–0.7624) and 0.7769 with 90% CI (0.6493–0.9295) respectively. Kinetic profiles between the two products were the same, however the test drug is relatively inferior compared to the reference drug.