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.