The Tolerability and Pharmacokinetics Clinical Trial of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The study is divided into three parts:

        1. The tolerance test of randomized，double-blind, placebo-controlled multiple-dose oral
           administrations.2 dosage groups are set up.Each group contains 8 subjects,evenly
           composed of men and women.The beginning dosage of the study is 160mg/L.Subjects who have
           successfully completed tests of the beginning dosage group and passed the safety
           assessment will enter the test of next dosage group(320mg/L) according to the same
           method.

        2. Pharmacokinetic tests(single/multiple dose) .(1)Single dosing pharmacokinetic tests.36
           eligible healthy subjects are selected. Each group has 12 people, evenly composed of men
           and women. After taking 80mg/160mg/320mg of PNA orally in fasting state, blood and urine
           samples are taken to be tested and analyzed, in order to study the pharmacokinetic
           characteristics of single-dose administrations.(2)Multiple dosing pharmacokinetic
           tests.In the single-dose administration trial, respectively choose 10 subjects (evenly
           composed of men and women) in middle and high-dose group (160mg qd、320mg qd).After the
           single-dose administration,inspecte the pharmacokinetic characteristics with 6-day
           continuous administration. Blood samples are taken to test the trough drug concentration
           of pre-dose in the morning of the 3rd, 4th, 5th day after administration, and the 6th
           morning before and after the administration, to study the steady state concentration and
           the fluctuation coefficient of the trough to peak drug concentration after
           multiple-dose, and to find out whether there exists the effect of drug storage and / or
           induction of drug enzyme.

        3. The effect of diet.Choose 12 qualified healthy subjects (normally evenly composed of men
           and women), a randomized two-way cross-over design is used, respectively orally take 160
           mg of PNA before and after meal, and to study the effect of diet on pharmacokinetic via
           blood collection.
    

Intervention name(s): PNA; PNA placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Metacavir Enteric-coated Capsules; Metacavir Enteric-coated Capsules placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B