Pharmacokinetics of Two Formulations of Entecavir

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850848
• Other study ID #: YSP RHH3001-01
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2016
• Last updated: July 27, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Yung Shin Pharm. Ind. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy adult, aged between 20 to 45 years old.

2. 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.

3. Body weight must be above 50 kg for male and 45 kg for female.

4. The normal range of the body mass index should be between 18 and 30; body mass index equals [weight (kg)]/[height (m)]2.

5. 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 (?-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.

6. 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.

7. Urinalysis results are within normal range or considered not clinically significant by the investigator, including: glucose, protein, RBC, WBC, epithelial cells, casts and bacteria.

8. 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.

9. Informed consent form signed.

Exclusion Criteria:

1. A history of drug or alcohol abuse during the past 24 weeks.

2. Sensitivity to analogous drug.

3. A clinically significant illness (such as lactic acidosis or severe hepatomegaly with steatosis) within the past 4 weeks.

4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.

5. Planned vaccination during the time course of the study.

6. Participation of any clinical investigation during the last 60 days.

7. Regular use of any medication during the last 4 weeks.

8. Single use of any medication during the last 2 weeks.

9. Blood donation of more than 250 mL within the past 12 weeks.

10. Employees and their families of sponsor and/or Contract Research Organization (CRO) company.

11. Individuals are judged by the investigator or co-investigator to be undesirable as subjects.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• Entigin Film Coated Tablet 0.5mg

• (Baraclude 0.5mg Tablets

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yung Shin Pharm. Ind. Co., Ltd.	Taichung Veterans General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Incidence of Treatment-Emergent Adverse Events		The safety was monitored throughout the study. Up to 10 weeks	Yes