Background: Hypertension is one of the leading causes of morbidity and mortality in Ethiopia. Treatment usually\ninvolves lifelong medication use. Enalapril is a common drug for the treatment of hypertension in Ethiopia. However,\nthe drug is expensive and, therefore, there is limited capacity for people to afford the treatment. Locally produced\nEnalapril is a cost-effective solution to treat the disease. However, as local medicines regulation does not include\nbioequivalence tests on locally produced drugs, physicians and patients need assurance about the effectiveness\nand safety of local generics. Evidence on therapeutic equivalence is needed on these untested local drugs.\nMethods: This is a hospital-based, randomized, partially blinded, three-cycle crossover trial in single patients,\ncomparing a locally produced version of enalapril with enalapril imported from Europe. Patients involved in this\ntrial are not blinded, as there is no local facility to produce relatively small numbers of placebos or encapsulated\ndrugs. To ensure blinding of study investigators and data analysts, study medications are prepared by an independent\npharmacy unit using opaque medication packaging. The importance of maintaining blinding is also part of patient\npre-trial education. Each N-of-1 trial will consist of three successive 14-day treatment pairs, each pair comprising\n7 days of 5ââ?¬â??20 mg local and 7 days of 5ââ?¬â??20 mg imported enalapril taken once daily in the morning. The primary\noutcome will be the average difference in systolic blood pressure as measured by home blood pressure measurements.\nDiscussion: The number of locally produced products, such as enalapril, being approved without proof of\nbioequivalence is dramatically increasing. By bridging the information gap on bioequivalence, the trial will give\nrigorous evidence on therapeutic equivalence of locally produced enalapril in the treatment of hypertension. If\nthere is no difference, the hypothesized result, then patients can take the local medicine with confidence. This trial will\nalso will determine whether aggregated N-of-1 studies are feasible to evaluate untested generic drugs in resourcelimited\ncountries where bioequivalence testing centers are unavailable.
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