The Tolerability and Pharmacokinetics Clinical Trial of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of
multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug
concentration in the plasma and urine after a single oral administration of different doses
of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are
estimated;3.By measuring the changing drug concentration in the plasma of PNA after a
multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters
of multiple-dose are estimated, and a basis for dosage regimens of the clinical research
phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the
changes of concentration of PNA in plasma after high-fat and high-calorie food.