- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03847246
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
February 19, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Entecavir Tablets 1.0 mg With Baraclude® 1.0 mg in Healthy Adult Subjects Under Fasting Conditions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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, and all subjects in each group will be crossed over to the alternate formulation and will be dosed on the same day for Day 22 of Period 2.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Ji'nan, Shandong, China, 250013
- Ji'nan Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Baraclude® tablets,1.0 mg
|
oral,once,under fasting condition
|
EXPERIMENTAL: Entecavir tablets,1.0 mg
|
oral,once,under fasting condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: Cmax will be obtained on Day 1 within 60 minutes pre-dose and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours and 72 hours post-dose.
|
Peak Plasma Concentration (Cmax) of Entecavir.
|
Cmax will be obtained on Day 1 within 60 minutes pre-dose and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours and 72 hours post-dose.
|
AUC0-t、AUC0-∞
Time Frame: AUC will be obtained on Day 1 within 60 minutes pre-dose and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours,24 hours, 48 hours and 72 hours post-dose.
|
Area under the plasma concentration versus time curve (AUC) of Entecavir.
|
AUC will be obtained on Day 1 within 60 minutes pre-dose and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours,24 hours, 48 hours and 72 hours post-dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 4, 2018
Primary Completion (ACTUAL)
December 28, 2018
Study Completion (ACTUAL)
December 28, 2018
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (ACTUAL)
February 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTTQ-2018-001-JN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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