Pharmacokinetics of Two Formulations of Entecavir

NCT02850848 | Completed Phase 4

• 1 other identifier: YSP RHH3001-01
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis B

Keywords

Pharmacokinetic

Outcome Measures

Primary Outcomes (6)

• Area under the plasma concentration(AUC)

  Plasma sample: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 84, 132 and 168 hr Urine sample: -2~0, 0~6, 6~12, 12~24, 24~36, 36~48 hr

• Time to reach Cmax(Tmax)

  Plasma sample: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 84, 132 and 168 hr Urine sample: -2~0, 0~6, 6~12, 12~24, 24~36, 36~48 hr

• Peak Drug Concentration(Cmax)

  Plasma sample: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 84, 132 and 168 hr Urine sample: -2~0, 0~6, 6~12, 12~24, 24~36, 36~48 hr

• Elimination half-life(T1/2)

  Plasma sample: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 84, 132 and 168 hr Urine sample: -2~0, 0~6, 6~12, 12~24, 24~36, 36~48 hr

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

  Plasma sample: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 84, 132 and 168 hr Urine sample: -2~0, 0~6, 6~12, 12~24, 24~36, 36~48 hr

• Mean Residence Time(MRT)

  Plasma sample: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 84, 132 and 168 hr Urine sample: -2~0, 0~6, 6~12, 12~24, 24~36, 36~48 hr

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  The safety was monitored throughout the study. Up to 10 weeks

Study Arms (2)

Entigin Film Coated Tablet 0.5mg

EXPERIMENTAL

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

Drug: Entigin Film Coated Tablet 0.5mg

Baraclude 0.5mg Tablets

ACTIVE COMPARATOR

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

Drug: (Baraclude 0.5mg Tablets

Interventions

Entigin Film Coated Tablet 0.5mg DRUG

Entigin Film Coated Tablet 0.5mg

(Baraclude 0.5mg Tablets DRUG

Baraclude 0.5mg Tablets

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead
• Taichung Veterans General Hospital: collaborator

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: August 1, 2016
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07