Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers
Abstract
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 AUC0-24, Cmax, Tmax, 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 AUC0-24, Cmax, Tmax, 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 Cmax and AUC0-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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 8 participants or records.
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