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.
Subject(s)
Volunteers , Adult , Humans , Therapeutic Equivalency , Pilot Projects , Indonesia , Single-Blind Method , Tablets , Area Under CurveABSTRACT
BACKGROUND: In Indonesia, diarrhea is an endemic disease and often leads fatal and an outbreak potential. Diarrhea can occur for several days and often can be cured without any medication. Commonly, to treat diarrhea atthe first time is by doing self-medication. Basic health survey data in 2013 showed that 15.7% of Indonesian people kept and used traditional medicines (TM). OBJECTIVE: This study was conducted to find out the characteristic of Indonesian people do for diarrhea self-medication. METHOD: We analyzes household data cross-sectionally from the 2013 basic health survey in 33 provinces and 497 cities in Indonesian. Data analysis included household characteristics, economic status, education, information of getting and keeping the TM, and status of the TM kept in households. RESULT: The result showed 89% of households store traditional medicines. Traditional diarrhea medicines were stored by 66.54% households in the urban, and were mostly obtained from traditional medicine store, stored for supply 55.86%, and used only if needed 50.65%. CONCLUSION: The study concluded that mostly people preferred to keep and use traditional Indonesian medicine produced by the TM national industry rather than others. Duration of use for self-medication in most of the households is thought to be appropriate.
