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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Feb 19, 2019

Keywords

ClinConnect Summary

This is 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. Each subject will be randomized to one of two treatment sequences (TR, RT) according to a randomization schedule prepared prior to the start of the study. There will be a 21-day washout between each single dose administration. Subjects in each group will be dosed on the same day for Day 1 of Period 1,...

Gender

ALL

Eligibility 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.