Relative bioavailability and pharmacokinetics of ferrous fumarate soft capsule

Objective: To investigate the relative bioavailability and pharmacokinetics of Ferrous Fumarate soft capsule, and to evaluate the bioequivalence between the soft capsule and oral solution. Methods: 0.56 g oral solution (or 0.6 g soft capsule) was given to 10 healthy volunteers according to cross over design. Drug concentrations in serum were assayed by atomic absorption spectrometry. The pharmacokinetic parameters were measured by 3P87 program. Results: The concentration-time curve of Ferrous Fumarate soft capsule was fitted to one-compartment open model. The pharmacokinetic parameters of Ferrous Fumarate oral solution and Ferrous Fumarate soft capsule: were tmax 4.50 h; cmax(1.66&plusmn0.11) mg·L-1 and (1.85&plusmn0.32) mg·L-1; t1/2(1.27&plusmn0.12) h and (1.18&plusmn0.09) h; AUC0 to approximately infinity(5.21&plusmn0.39) mg·h·L-1 and (5.44&plusmn0.30) mg·h·L-1, respectively. The relative bioavailability of Ferrous Fumarate soft capsule was 97.75%. Conclusion: The pharmacokinetic parameters between two products had no significant difference (Pgt;0.05). The two formulations were of bioequivalence.