OBJECTIVE: To assess bioequivalence between an intact capsule and the content of a capsule sprinkled on applesauce. MATERIALS: Medikinet retard 20 mg capsules were obtained from Medice (Iserlohn, Germany). METHODS: This was a single-center, completely randomized, open, 2-period, 2-sequence, balanced crossover study with a washout period of 1 week between administrations, in 12 healthy male and female subjects, aged 18-45 years. Blood samples were collected over 24 hours and methylphenidate plasma concentration-time data were used to calculate pharmacokinetic parameters for both administrations. The main parameters were (confirmatory) AUC0-tz (extent of BA), Cmax, tmax (rate of BA) and (descriptively) AUC0-infinity and t1/2. Equivalence was concluded if the 90% confidence interval (CI) for the ratio between test and reference was 0.80-1.25 (AUC0-tz). RESULTS: All 12 dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses. 90% geometric confidence intervals for AUC0-tz and Cmax data were well within accepted bioequivalence limits. The study has shown that both treatment modes lead to similar pattern of absorption and elimination following single-dose administration in the fed state. The test treatment (content of capsule sprinkled over 15 ml applesauce) is bioequivalent to the reference treatment (intact capsule) in terms of extent and rate of absorption. CONCLUSION: Data collected from this study demonstrate that Medikinet retard capsules can be opened and the content sprinkled on a tablespoon of applesauce without influencing the rate and extent of bioavailability.
RCT Entities:
OBJECTIVE: To assess bioequivalence between an intact capsule and the content of a capsule sprinkled on applesauce. MATERIALS: Medikinet retard 20 mg capsules were obtained from Medice (Iserlohn, Germany). METHODS: This was a single-center, completely randomized, open, 2-period, 2-sequence, balanced crossover study with a washout period of 1 week between administrations, in 12 healthy male and female subjects, aged 18-45 years. Blood samples were collected over 24 hours and methylphenidate plasma concentration-time data were used to calculate pharmacokinetic parameters for both administrations. The main parameters were (confirmatory) AUC0-tz (extent of BA), Cmax, tmax (rate of BA) and (descriptively) AUC0-infinity and t1/2. Equivalence was concluded if the 90% confidence interval (CI) for the ratio between test and reference was 0.80-1.25 (AUC0-tz). RESULTS: All 12 dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses. 90% geometric confidence intervals for AUC0-tz and Cmax data were well within accepted bioequivalence limits. The study has shown that both treatment modes lead to similar pattern of absorption and elimination following single-dose administration in the fed state. The test treatment (content of capsule sprinkled over 15 ml applesauce) is bioequivalent to the reference treatment (intact capsule) in terms of extent and rate of absorption. CONCLUSION: Data collected from this study demonstrate that Medikinet retard capsules can be opened and the content sprinkled on a tablespoon of applesauce without influencing the rate and extent of bioavailability.
Authors: Akwete Adjei; Robert J Kupper; Nathan S Teuscher; Sharon Wigal; Floyd Sallee; Ann Childress; Scott H Kollins; Laurence Greenhill Journal: Clin Drug Investig Date: 2014-11 Impact factor: 2.859