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Pharmacokinetics of Two Formulations of Entecavir

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Entigin Film Coated Tablet 0.5mg

(Baraclude 0.5mg Tablets

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Pharmacokinetic

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult, aged between 20 to 45 years old.
Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.
- no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to administration of study medication.
- normal or considered not clinically significant by the investigator chest X-ray and Electrocardiogram (ECG) results within six months(180 days)prior to administration of study medication.
Body weight must be above 50 kg for male and 45 kg for female.
The normal range of the body mass index should be between 18 and 30; body mass index equals [weight (kg)]/[height (m)]2.
Laboratory determinations results are within normal range or considered not clinically significant by the investigator, including: Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), albumin, glucose, creatinine, uric acid, cholesterol, Triglycerides (TG), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, Blood Urea Nitrogen (BUN), Hepatitis B surface antigen (HBsAg), Anti-Hepatitis C virus (HCV) and Anti-Human Immunodeficiency Virus (HIV) test.
Hematology test results are within normal range or considered not clinically significant by the investigator, including: hemoglobin, hematocrit, White Blood Cell (WBC) count, Red Blood Cell (RBC) count, platelet count and WBC count with differential.
Urinalysis results are within normal range or considered not clinically significant by the investigator, including: glucose, protein, RBC, WBC, epithelial cells, casts and bacteria.
Female subject who is:
- using adequate contraception since last menstruation and no plan for conception during the study.
- non-lactating.
- has negative pregnancy test (urine) prior to the study.
Informed consent form signed.

Exclusion Criteria:

A history of drug or alcohol abuse during the past 24 weeks.
Sensitivity to analogous drug.
A clinically significant illness (such as lactic acidosis or severe hepatomegaly with steatosis) within the past 4 weeks.
Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
Planned vaccination during the time course of the study.
Participation of any clinical investigation during the last 60 days.
Regular use of any medication during the last 4 weeks.
Single use of any medication during the last 2 weeks.
Blood donation of more than 250 mL within the past 12 weeks.
Employees and their families of sponsor and/or Contract Research Organization (CRO) company.
Individuals are judged by the investigator or co-investigator to be undesirable as subjects.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Entigin Film Coated Tablet 0.5mg

Baraclude 0.5mg Tablets

Arm Description

Entigin Film Coated Tablet 0.5mg Dosing Regimen: Single dosing of two tablets

Baraclude 0.5mg Tablets Dosing Regimen: Single dosing of two tablets

Outcomes

Primary Outcome Measures

Area under the plasma concentration(AUC)

Time to reach Cmax(Tmax)

Peak Drug Concentration(Cmax)

Elimination half-life(T1/2)

Area under the (first) moment plasma concentration-time curve(AUMC)

Mean Residence Time(MRT)

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Full Information

NCT ID

NCT02850848

First Posted

June 16, 2016

Last Updated

July 27, 2016

Sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Collaborators

Taichung Veterans General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02850848

Brief Title

Pharmacokinetics of Two Formulations of Entecavir

Official Title

A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent Dose of a Reference Drug Product (Baraclude 0.5mg Tablets) in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Collaborators

Taichung Veterans General Hospital

4. Oversight

5. Study Description

Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Pharmacokinetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Entigin Film Coated Tablet 0.5mg

Arm Type

Experimental

Arm Description

Entigin Film Coated Tablet 0.5mg Dosing Regimen: Single dosing of two tablets

Arm Title

Baraclude 0.5mg Tablets

Arm Type

Active Comparator

Arm Description

Baraclude 0.5mg Tablets Dosing Regimen: Single dosing of two tablets

Intervention Type

Drug

Intervention Name(s)

Entigin Film Coated Tablet 0.5mg

Intervention Type

Drug

Intervention Name(s)

(Baraclude 0.5mg Tablets

Primary Outcome Measure Information:

Title

Area under the plasma concentration(AUC)

Time Frame