The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.

• 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 18 and below 28 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. No smoking in a year before post-dosing of study drug;

5. Give their signed written informed consent to participate.

Exclusion Criteria:

1. Subjects who have clinically significant abnormal laboratory test results;

2. Subjects with clinically significant abnormal ECG;

3. Subjects with cardiac or blood disease affecting the safety and pharmacokinetics;

4. Subjects with liver or renal disease affecting the safety and pharmacokinetics;

5. Subjects with digestive system disease affecting the safety of study drug;

6. Subjects with other acute or chronic disease affecting pharmacokinetics and product metabolism;

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

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

9. Subjects, who in the opinion of the investigator, significantly abuse alcohol;

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

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

12. Drug abuse,a history of poisoning;

13. Smokers(use tobacco products in a year before post-dosing of study drug);

14. 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;

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

16. Subjects who had suffered from hemorrhage or blood donation over 200ml will be excluded; 17. Subjects over exercised accompanied with fatigue and muscle aches within 1 week period to the administration of Investigational Product;

18．Children,women who are pregnant,lactating,with childbearing potential and who are using acyeterions; 19．Haven't given their signed written informed consent to participate; 20．Subjects in the opinion of the investigator, could not participate in this study.