Blood Sampling and Study assessment
The samples were drawn by a short intravenous catheter at pre-dose and at 0.17, 0.25, 0.50, 0.75, 1.00, 1.33, 1.66, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 14.00,and 24.00 hours post-dose in each clinical study period, and they were collected into polypropylene tubes using K2 EDTA as anti-coagulating agent.
Volunteers were hospitalized at FARMAGEN-Good Clinical Practice Center after isolation period during the clinical study. An evening meal was provided at hospitalization days (total caloric value of approximately 1200 kcal during study period. On medication days, a standard lunch (total caloric value is approximately 1200 kcal) was provided 4 hours after dosing, and a standard evening meal (total caloric value is approximately 1200 kcal) was provided 10 hours after dosing in each period Also standard light breakfast was provided in the evenings during hospitalization.
The blood samples were taken by a short intravenous catheter and they were collected into polypropylene tubes using K2 EDTA as anti-coagulating agent. After sampling, the samples were immediately refrigerated at approximately 2-8°C and will remain there for not more than 30 minutes. Following the centrifugation (3.000 rpm, 4 - 6°C, 10 min), the separated plasma from each sample were transferred into two 3 mL transparent, polypropylene tubes. All the aliquoted plasma samples will be flash freezing immediately. The flash frozen samples (aliquoted plasma samples) were transferred to a deep-freezer and stored at -70°C until they were transported to the bioanalytical center.