Summary of bioequivalence study for Darfen, coated tablets (ibuprofen)
Purpose. To prove the bioequivalence (BE) of the test investigational medicinal product (IMP) Darfen, 400 mg ibuprofen coated tablets (which corresponds to 512 mg of ibuprofen sodium dihydrate), manufactured by PrJSC “Pharmaceutical Firm “Darnytsia” to the reference IMP Nurofen® Forte Express, 400 mg ibuprofen coated tablets (which corresponds to 512 mg of ibuprofen sodium dihydrate), manufactured by Reckitt Benckiser (Poland) S.A., in a randomized, open-label, single-dose, two-sequence, two-period, crossover, comparative, oral bioequivalence study in 32 healthy volunteers under fasting conditions.
Objects and methods of the study. In each study period, healthy male and female volunteers took a single oral dose of test or reference IMPs, i.e., 400 mg of ibuprofen (i.e., 800 mg of ibuprofen throughout the study) under fasting conditions. Data of thirty-one (31) healthy volunteers fully completed the study according to the protocol and taken IMP in both periods were included in pharmacokinetic and statistical analysis.
Results. Pharmacokinetic results demonstrate that ibuprofen geometric least squares mean (LSM) ratios and corresponding 90% confidence intervals (CIs) for maximum plasma concentration of ibuprofen (Cmax) and area under the plasma concentration curve from administration to last observed concentration at time (t) (AUC0-t) were 93.11% (87.48 to 99.11%) and 99.16% (95.94 to 102.49%), respectively.
The criteria used to assess bioequivalence between the test and reference IMPs were all fulfilled since the Test to Reference ratio of geometric LSM and corresponding 90% CI for Cmax and AUC0-t were all within the acceptance range of 80.00 to 125.00%.
During the study, no clinically significant and drug-related changes were detected in healthy volunteers based on the assessment of vital signs, physical examination, electrocardiography, and laboratory tests.
The drugs tested were safe and well tolerated by healthy volunteers that were included in this study.
Conclusions. The bioequivalence of the test IMP Darfen, 400 mg ibuprofen coated tablets, manufactured by PrJSC “Pharmaceutical Firm “Darnytsia” to the reference IMP Nurofen® Forte Express, 400 mg ibuprofen coated tablets, manufactured by Reckitt Benckiser (Poland) S.A., was demonstrated in this study.
The Sponsor of the study, PrJSC “Pharmaceutical Firm “Darnytsia”, expresses its gratitude to the employees of contract research organization ACDIMA Center for Bioequivalence and Pharmaceutical Studies (Amman, Jordan) for conducting this study and processing its results.