A Single-Dose, Randomized

A single-dose, randomized, two-way crossbreeding engage comparing two olanzapine tablet products in healthy adult manlike volunteers under fasting conditions Clinical Therapeutics, Volume 31, Issue 3, March 2009, Pages 600-608 Ahmed H. Elshafeey, Mohamed A. Elsherbiny, Mohsen M. Fathallah Methods This bioequivalence piece of work was carried out in healthy male volunteers victimisation a single-dose, randomized, 2-way crossover design under fasting conditions.Statistical analysis of the pharmacokinetic parameters Cmax, AUC0-72, and AUC0-? was conducted to determine bioequivalence (after log-transformation of data using analysis of variance and 90% CIs) and to gain marketing approval in Egypt. The formulations were considered to be bioequivalent if the log-transformed ratios of the 3 pharmacokinetic parameters were within the predetermined bioequivalence stove (ie, 80% one hundred twenty-five%), as established by the US Food and Drug brass section (FDA).Both the test product (T rademark Integrol Global Napi Pharmaceuticals, Cairo, Egypt) and the reference product (Trademark Zyprexa Eli Lilly and Company, Basingstoke, Hampshire, United Kingdom) were administered as 10-mg tablets with 240 mL of water after an overnight fast on 2 intervention days, separated by a 2-week washout period. After dosing, serial breed samples were collected for 72 hours. Plasma samples were analyzed using a sensitive, reproducible, and right liquid chromatography-tandem mass spectrometry method capable of quantitating olanzapine in the range of 0. 67 to 16. 7 ng/mL, with a lower limit of quantitation of 0. 167 ng/mL. Adverse events were reported by the volunteers as instructed or observed by the resident physician, and were recorded, tabulated, and evaluated. Results Twenty-four healthy adult male volunteers participated in this poll. Their entail (SD) age was 24. 7 (6. 2) years (range, 1941 years), mean exercising weight was 73. 4 (6. 7) kg (range, 6489 kg), and mean height was 174. 25 (4. 6) cm (range, 168186 cm).Values for Cmax, AUC0-72, AUC0-? Tmax, t1/2, and the terminal disposition rate constant were found to be in agreement with previously reported values. The differences between the 2 products did non reach statistical significance at P ? 0. 05 (90% CIs Cmax, 101. 82124. 79 AUC0-72, 93. 36102. 04 and AUC0-? , 88. 57101. 77). The test/reference ratio of these parameters was within the toleration range of the FDA criterion for bioequivalence. Both formulations were apparently well absorbed from the astrointestinal brochure (ie, no specific gastrointestinal tract-related adverse events were reported). Conclusions In this small study in healthy male volunteers, there were no statistically evidentiary differences in any of the calculated pharmacokinetic parameters between the 10-mg test and reference tablets of olanzapine. The 90% CIs for the ratios of mean Cmax, AUC0-72, and AUC0-? were within the range of 80% to 125% (using log-transformed data ), meeting the FDA regulative criterion for bioequivalence. Both formulations were well tolerated.