Hepatitis BPhase 4NCT02850848
Pharmacokinetics of Two Formulations of Entecavir
A Phase 4 study testing Entigin Film Coated Tablet 0.5mg and (Baraclude 0.5mg Tablets in people with Hepatitis B, run by Yung Shin Pharm. Ind. Co., Ltd..
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 Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entigin Film Coated Tablet 0.5mg and (Baraclude 0.5mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- Being tested
- Entigin Film Coated Tablet 0.5mg, (Baraclude 0.5mg Tablets
- Keywords
- Pharmacokinetic
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entigin Film Coated Tablet 0.5mgDrug
(Baraclude 0.5mg TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Entigin Film Coated Tablet 0.5mg | Experimental | Entigin Film Coated Tablet 0.5mg Dosing Regimen: Single dosing of two tablets Receives: Drug: Entigin Film Coated Tablet 0.5mg |
| Baraclude 0.5mg Tablets | Active comparator | Baraclude 0.5mg Tablets Dosing Regimen: Single dosing of two tablets Receives: Drug: (Baraclude 0.5mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration(AUC)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: The safety was monitored throughout the study. Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taichung Veterans General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850848
- Sponsor's protocol ID
- YSP RHH3001-01
- Status last verified
- Jul 2016
- First submitted
- 16 Jun 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02850848
- Acronym / sponsor ID
- YSP RHH3001-01
- Conditions
- Hepatitis B
- Keywords
- Pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taichung Veterans General Hospital
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entigin Film Coated Tablet 0.5mg | Experimental | Drug: Entigin Film Coated Tablet 0.5mgEntigin Film Coated Tablet 0.5mg Dosing Regimen: Single dosing of two tablets |
| Baraclude 0.5mg Tablets | Active comparator | Drug: (Baraclude 0.5mg TabletsBaraclude 0.5mg Tablets Dosing Regimen: Single dosing of two tablets |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entigin Film Coated Tablet 0.5mg | Drug | Entigin Film Coated Tablet 0.5mg |
| (Baraclude 0.5mg Tablets | Drug | Baraclude 0.5mg Tablets |
Primary outcome
Area under the plasma concentration(AUC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: The safety was monitored throughout the study. Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entigin Film Coated Tablet 0.5mg and (Baraclude 0.5mg Tablets in people with Hepatitis B, run by Yung Shin Pharm. Ind. Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration(AUC) (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.