HepatitisPhase 1NCT02920931
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
A Phase 1 study testing Tenofovir disoproxil in people with Hepatitis, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis
- What is being tested?
- Tenofovir disoproxil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Apr 2016
- Phase
- Phase 1
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject, aged 19- 45 years at screening.
- Body weight of ≥ 55 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
- Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
Who cannot join
- A clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system.
- A history of gastrointestinal system disorder(i.e, Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (excluding simple appendectomy or herniorrhaphy) that may affect absorption of investigational drugs.
- A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
- Vital sign measured in sitting position meets any one of following results; systolic blood pressure > 140 mmHg or <100 mmHg, diastolic blood pressure > 90 mmHg or <60 mmHg, pulse ≥ 100 times/min.
- Aspartate aminotransferase(AST) or Alanine aminotransaminase(ALT) > 2 times upper normal limit, or Total bilirubin > 2 times upper normal limit.
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- Renal disorder (Creatinine clearance < 50 mL/min, calculated by Cockcroft-Gault formula)
- Positive in serologic tests (RPR Ab(VDRL), HBsAg, hepatitis C virus (HCV) Ab, anti HIV(AIDS))
- History of drug abuse, or positive in drug screening test.
- Use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate.
- Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of investigational drug, and this will affect this study or the safety of the subjects at discretion of study investigator.
- Participation in another clinical trial or a bioequivalent study within 3 months prior to the first administration of investigational drug (The finish time of previous study is the day of the last administration of study drug)
- Whole blood donation within 2 months or component donation within 1 month, prior to the first administration of investigational drug, or transfusion within 1 month prior to the first administration of investigational drug.
- Prolonged excessive alcohol consumption (>21 units/week, 1 unit=10g of pure alcohol), or subjects who can not abstain from drinking from 24 hours prior to hospitalization until the discharge.
- Smoking more than 10 cigarettes per day, excessive caffeine consumption (example: instant coffee > 5 cups/day)
- Subjects planning to get a dental treatment(tooth extraction, orthodontic treatment, endodontic treatment etc) and a selective surgery(aesthetic surgery, LASIK, LASEK etc) during the period from informed consent form(ICF) to post-study visit, which is impossible to be postponed.
- Subjects who are judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
Trial locations and contacts
1 site in 1 country.
About this study
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers.
- Conditions
- Hepatitis
- Being tested
- Tenofovir disoproxil
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxilDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1. st period: Tenofovir disoproxil fumarate
2. nd period: Tenofovir Disoproxil Receives: Drug: Tenofovir disoproxil |
| B | Active comparator | 1. st period: Tenofovir disoproxil
2. nd period: Tenofovir Disoproxil fumarate Receives: Drug: Tenofovir disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration(Cmax) of Tenofovir
Measured: 0~72 hour after medication
Area under the curve(AUCt) of Tenofovir
Measured: 0~72 hour after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang Hee Hong, PhD, Principal investigator, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920931
- Sponsor's protocol ID
- BR-TND-CT-101
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02920931
- Acronym / sponsor ID
- BR-TND-CT-101
- Conditions
- Hepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Sep 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, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tenofovir disoproxil1. st period: Tenofovir disoproxil fumarate 2. nd period: Tenofovir Disoproxil |
| B | Active comparator | Drug: Tenofovir disoproxil1. st period: Tenofovir disoproxil 2. nd period: Tenofovir Disoproxil fumarate |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subject, aged 19- 45 years at screening.
- Body weight of ≥ 55 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
- Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
Key exclusion criteria (17 listed)
- A clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system.
- A history of gastrointestinal system disorder(i.e, Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (excluding simple appendectomy or herniorrhaphy) that may affect absorption of investigational drugs.
- A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
- Vital sign measured in sitting position meets any one of following results; systolic blood pressure > 140 mmHg or <100 mmHg, diastolic blood pressure > 90 mmHg or <60 mmHg, pulse ≥ 100 times/min.
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 |
|---|---|---|
| Tenofovir disoproxil | Drug | A, B |
Primary outcome
Maximum observed concentration(Cmax) of Tenofovir
Time frame: 0~72 hour after medication
Area under the curve(AUCt) of Tenofovir
Time frame: 0~72 hour after medication
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 26 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Jang Hee Hong, PhD principal investigator
Chungnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir disoproxil in people with Hepatitis, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
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 5 inclusion and 17 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum observed concentration(Cmax) of Tenofovir (time frame: 0~72 hour after medication). The study lists 2 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 26 Jan 2017.