Healthy Subjects Clinical Trial
Official title:
Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study
The single-dose randomized, open-label, two-period crossover study was executed in the Phase
I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the
random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of
1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research
Center, and fasted for 10 hours overnight until administration. The medicine was swallowed
with 240 ml water at room temperature. Blood samples were taken before administration and at
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after
administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the
plasma. The plasma samples were divided into two aliquots and stored at -80 °C until
bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval
between two administration, is 21 days. In the two periods, the operation was kept the same.
Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour
before taking the medicine. Other procedures were the same as those in the fasting group.
n/a
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