Abstract
In this 2 × 2, randomized, crossover bioequivalence study, two tablet preparations
of helicidum were compared in 20 healthy Chinese male subjects. The drug was given
in a single dose of three tablets (75 mg) and blood samples were withdrawn during
12 h after drug administration. Helicidum was separated and analyzed using a validated
liquid chromatography-mass spectrum method. The pharmacokinetic parameters were determined
from the plasma concentration-time profiles of both formulations. The primary calculated
pharmacokinetic parameters were compared statistically to evaluate bioequivalence
between the two preparations, using various statistical methods.
The analysis of variance (ANOVA) did not show any significant difference between the
two formulations and 90 % confidence intervals fell within the acceptable range (80-120
%) for bioequivalence. Based on these statistical inferences it can be concluded that
the two tablet preparations of helicidum are likely to be bioequivalent.
Key words
Helicid hilagirica Beed
- Helicidum, bioequivalence, pharmacokinetics
