Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers

• Status: Completed
• Trial end date: 2018-12-28
• Target enrollment: 0
• Participant gender: All

Summary

A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®) 1.0 mg in healthy adult subjects under fasting conditions.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Entecavir

Criteria

Inclusion Criteria:

1. Able to give signed Informed Consent Form before study, and fully understand the study content, process and possible adverse reactions;

2. Able to complete the study in compliance with the protocol;

3. Subjects (including male subjects) agree to adopt effective contraceptive measurements and not plan pregnancy from 14 days before screening to 6 months after study completion;

4. Healthy male and female subjects between 18 and 50 years of age, inclusive;

5. At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2 kg/m2) between 18.0-28.0, inclusive.

Exclusion Criteria:

1. More than 5 cigarettes per day on average within 3 months before the study;

2. A history of allergies (such as asthma, measles, eczema, etc.), or allergic constitution (allergic to two or more drugs or food such as milk and pollen), or a history of allergy to Entecavir and its inactive ingredient;

3. A history of alcohol abuse (at least 14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines);

4. Donation or loss of a significant volume of blood (> 400 mL) within 3 months prior to receiving study medication;

5. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;

6. History of Lactic acidosis and / or severe hepatomegaly with steatosis;

7. Use of any prescription drugs within 14 days prior to receiving study medication;

8. Use of any over-the-counter (OTC) drugs, dietary or herbal supplements within 7 days prior to receiving study medication;

9. Consumption of any special diet (including grapefruit and products containing grapefruit) or subjects have exercised strenuously or have any other factors affecting drug absorption, distribution, metabolism and excretion within 7 days prior to receiving study medication.

10. Participation in other drug clinical study within 3 months prior to receiving study medication;

11. Any clinically significant abnormalities/findings, as judged by the Investigator, including laboratory tests, vital signs, electrocardiogram, and physical examination; Or have a serious history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities, which the Investigator considers inappropriate for participants;

12. A positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody or syphilis;

13. Consumption of chocolate or any food or beverages containing caffeine or (rich containing) xanthine within 48 h prior to receiving study medication;

14. Consumption of any product containing alcohol within 24 h prior to receiving study medication or a positive result of alcohol test;

15. A positive test result for drug screening or a history of drug abuse within 5 years or use of any controlled substances within 3 months before the study;

16. A positive pregnancy test or subject is lactating during screening or study period if the subject is female;

17. Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study.