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

NCT03847246 | Completed

• 1 other identifier: CTTQ-2018-001-JN
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 entecavir tablets (Baraclude®) 1.0 mg in healthy adult subjects under fasting conditions.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• Cmax

  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-∞

  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.

Study Arms (2)

Baraclude® tablets，1.0 mg

ACTIVE COMPARATOR

Drug: Baraclude® tablets,1.0 mg

Entecavir tablets，1.0 mg

EXPERIMENTAL

Drug: Entecavir tablets,1.0 mg

Interventions

Baraclude® tablets,1.0 mg DRUG

oral,once,under fasting condition

Baraclude® tablets，1.0 mg

Entecavir tablets,1.0 mg DRUG

oral,once,under fasting condition

Entecavir tablets，1.0 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Ji'nan Central Hospital

Ji'nan, Shandong, 250013, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 20, 2019
• Study Start: December 4, 2018
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

CN (1)