Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults.

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Summary of "Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults."

The angiotensin-converting enzyme inhibitor enalapril is commonly used to treat chronic heart failure in children. Because some children are unable to swallow capsules or tablets, a new, age-appropriate, orodispersible minitablet (ODMT) containing 1 mg of enalapril was developed within the EU-funded LENA (Labeling of Enalapril from Neonates up to Adolescents) consortium. In order to support the clinical evaluation of this new formulation in children, a relative bioavailability study was performed in healthy adults, comparing the bioavailability of enalapril in the ODMT with that of a reference product (RP) Renitec, a registered standard enalapril tablet formulation. In this open-label, randomized 3-way crossover study, 24 healthy subjects received a 10-mg enalapril dose administered as (1) 2 × 5-mg tablets of the RP swallowed with water, (2) 10 × 1-mg ODMT swallowed with water, and (3) 10 × 1 mg ODMT dispersed on the tongue. When the relative bioavailability of the ODMT formulation swallowed with water was compared with that of the RP, the estimated 90%CIs for the ratio of area under the concentration-time curve (AUC ) and or peak concentration (C ) of enalapril were 92.34% to 106.49% and 91.28% to 115.72%, respectively, which are within the accepted bioequivalence limits of 80% to 125%. Following dispersion of the ODMT in the mouth, a slightly higher C for enalapril was observed as compared with the RP with an upper 90%CI of 127.57%, slightly exceeding the bioequivalence limit. Taken together, it was demonstrated that the method of administration of the ODMT, swallowed or dispersed, did not significantly affect the bioavailability of enalapril.


Journal Details

This article was published in the following journal.

Name: Clinical pharmacology in drug development
ISSN: 2160-7648


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Medical and Biotech [MESH] Definitions

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Coded listings of physician or other professional services using units that indicate the relative value of the various services they perform. They take into account time, skill, and overhead cost required for each service, but generally do not consider the relative cost-effectiveness. Appropriate conversion factors can be used to translate the abstract units of the relative value scales into dollar fees for each service based on work expended, practice costs, and training costs.

One of the ANGIOTENSIN-CONVERTING ENZYME INHIBITORS that is used to treat hypertension.

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