Key result
Enalapril RAPIDISC wafer proves bioequivalent to conventional enalapril tablets.
Why the study?
Enalapril in RAPIDISC wafer formulation may improve convenience and adherence to antihypertensive treatment, but its bioequivalence to conventional tablets needed evaluation.
Does 20 mg enalapril wafer demonstrate bioequivalence to the conventional 20 mg enalapril tablet in healthy male volunteers?
RCT (n=16)
Open-label
Does 20 mg enalapril wafer demonstrate bioequivalence to the conventional 20 mg enalapril tablet in healthy male volunteers?
Effect estimate: Geometric mean ratio 1.03 (95% CI 0.93-1.15)
Absolute Event Rate: 5.13% vs 5.03%
The 20 mg enalapril RAPIDISC wafer formulation is bioequivalent to the conventional 20 mg tablet, offering a potentially more convenient administration option.
Supports wafer development for convenience; leaves open patient outcomes and adherence data.
BACKGROUND: Enalapril in RAPIDISC* (wafer), a new easy-to-administer formulation of enalapril, may improve the convenience of enalapril therapy, thereby helping patients adhere to antihypertensive treatment. SUBJECTS AND METHODS: To determine whether 20 mg enalapril wafer is bioequivalent to the conventional 20 mg enalapril tablet, an open-label, two-period crossover study was performed in 16 healthy male volunteers. Cumulative urinary recovery of free enalaprilat (active metabolite of enalapril) and the serum maximum concentration of free enalaprilat (Cmax) were the primary pharmacokinetic parameters used to determine bioequivalence in this study. Bioequivalence was defined as the geometric mean ratio (wafer: tablet) falling within the equivalence limits of 0.80 to 1.25 for both parameters. RESULTS: Cumulative urinary recovery of free enalaprilat (0 - 72 hours) was similar between the wafer and conventional tablet formulations (arithmetic mean 5.13 vs. 5.03 mg, about 36% of dose). The geometric mean ratio of the urinary recovery of free enalaprilat (wafer: tablet) was 1.03 (90% CI: 0.93, 1.15). Cmax of serum enalaprilat was also similar between the wafer and conventional tablet formulations (arithmetic mean 85.7 vs. 76.3 ng/ml). The geometric mean Cmax ratio (wafer: tablet) was 1. 10 (90% CI: 1.00, 1.22). Both enalapril formulations were well tolerated. CONCLUSION: This study demonstrates that 20 mg enalapril in RAPIDISC is bioequivalent to 20 mg enalapril conventional tablet.
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M-W et al. (2000) conducted an RCT in Healthy volunteers (n=16). Enalapril in RAPIDISC (wafer formulation) vs. 20 mg enalapril conventional tablet was evaluated on Cumulative urinary recovery of free enalaprilat (Geometric mean ratio 1.03, 95% CI 0.93-1.15). Enalapril 20 mg in RAPIDISC wafer formulation was bioequivalent to the conventional 20 mg tablet, with a geometric mean ratio for urinary recovery of 1.03 (90% CI 0.93-1.15).
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