Status:
COMPLETED
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 ent...
Detailed Description
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 formula...
Eligibility Criteria
Inclusion
- Able to give signed Informed Consent Form before study, and fully understand the study content, process and possible adverse reactions;
- Able to complete the study in compliance with the protocol;
- 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;
- Healthy male and female subjects between 18 and 50 years of age, inclusive;
- 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
- More than 5 cigarettes per day on average within 3 months before the study;
- 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;
- 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);
- Donation or loss of a significant volume of blood (\> 400 mL) within 3 months prior to receiving study medication;
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
- History of Lactic acidosis and / or severe hepatomegaly with steatosis;
- Use of any prescription drugs within 14 days prior to receiving study medication;
- Use of any over-the-counter (OTC) drugs, dietary or herbal supplements within 7 days prior to receiving study medication;
- 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.
- Participation in other drug clinical study within 3 months prior to receiving study medication;
- 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;
- A positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody or syphilis;
- Consumption of chocolate or any food or beverages containing caffeine or (rich containing) xanthine within 48 h prior to receiving study medication;
- Consumption of any product containing alcohol within 24 h prior to receiving study medication or a positive result of alcohol test;
- 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;
- A positive pregnancy test or subject is lactating during screening or study period if the subject is female;
- Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study.
Key Trial Info
Start Date :
December 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03847246
Start Date
December 4 2018
End Date
December 28 2018
Last Update
February 20 2019
Active Locations (1)
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1
Ji'nan Central Hospital
Ji'nan, Shandong, China, 250013