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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

Criteria

Inclusion Criteria:

1. Healthy volunteers aged 18 to 45 years old ;

2. Body mass index (BMI) above/equal 19 and below 24 kg/m2;

3. Child bearing potential, has a negative serum pregnancy test at screening period, and agrees to use contraceptions consistently and correctly in 14 days after dosing;

4. Subjects with no cardiovascular, liver, kidney, digestive tract, nervous and mental and other acute or chronic diseases that may affect the safety and pharmacokinetic of drug;

5. Signed informed consent voluntarily.

Exclusion Criteria:

1. Subjects not meet the inclusion criteria;

2. Abnormal clinically significant laboratory results;

3. Abnormal clinically significant electrocardiogram (ECG);

4. A positive hepatitis B surface antigen, hepatitis C or HIV test result;

5. History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes;

6. Addicted to smoking and drinking;

7. Drink in 36 hours before post-dosing of study drug;

8. Ingest any foods or beverages which may affect pharmacokinetics;

9. Drug abuse,a history of poisoning;

10. Subjects who had received other medications within 2 weeks prior to the first administration of Investigational Product，and the original and main metabolites were not completely eliminated ;

11. Subjects who participated in any other clinical trials within 3 months prior to the first administration of Investigational Product;

12. Subjects who had suffered from hemorrhage or blood donation over 200ml will be excluded;

13. Subjects over exercised accompanied with fatigue and muscle aches within 1 week period to the first administration of Investigational Product;

14. Children,women who are pregnant,lactating,with childbearing potential and who are using acyeterions;

15. Subjects in the opinion of the investigator, could not participate in this study.