HealthyPhase 1NCT02902523
Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers
A Phase 1 study testing Viread® tablet 300mg and HUG116 tablet 245mg in people with Healthy, run by Huons 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 HUG116 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
- Healthy
- What is being tested?
- Viread® tablet 300mg and HUG116 tablet 245mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Nov 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
- Age between 19 to 45, healthy male subjects(at screening)
- Body weight over 55kg, in the range of calculated Ideal Body Weight ± 20%
- Subject without a hereditary problems, chronic disease and morbid symptom
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Who cannot join
- Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
- Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- Volunteer who had hypersensitivity reaction to medicines including Tenofovir
- Volunteer who has genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance
- Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
- Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
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- Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
- Have the result of serum test(RPR Ab(VDRL), HBsAg, HCV Ab, Anti HIV(AIDS)) is a positive
- History of drug abuse, or a positive urine drug screen
- Having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
- Participation in any other clinical trial involving investigational drugs within 3 months
- Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
- Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
- Volunteers smoking over 10 cigarettes per day in the last 3 months and taking a surfeit of caffeine(caffeine>400mg per day)
- Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
- Any condition that, in the view of the investigator, would interfere with study participation
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 HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers
- Conditions
- Healthy
- Being tested
- Viread® tablet 300mg, HUG116 tablet 245mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viread® tablet 300mgDrug
Single dose administration(PO) in the fasted state
HUG116 tablet 245mgDrug
Single dose administration(PO) in the fasted state
| Study group | Role | What they receive |
|---|---|---|
| Viread ® tablet 300mg | Active comparator | Tenofovir disoproxil fumarate Receives: Drug: Viread® tablet 300mg |
| HUG116 tablet 245mg | Experimental | Tenofovir disoproxil Receives: Drug: HUG116 tablet 245mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve(AUC)last of Tenofovir
Measured: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Maximum of concentration(Cmax) of Tenofovir
Measured: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Secondary outcomes (4)
Area Under Curve(AUC)inf of Tenofovir
Measured: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
tmax of Tenofovir
Measured: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
t1/2β of Tenofovir
Measured: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Clearance/F of Tenofovir
Measured: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902523
- Sponsor's protocol ID
- HUG-116 P1
- Status last verified
- Apr 2018
- First submitted
- 12 Sep 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02902523
- Acronym / sponsor ID
- HUG-116 P1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 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 HUG116 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 |
|---|---|---|
| Viread ® tablet 300mg | Active comparator | Drug: Viread® tablet 300mgTenofovir disoproxil fumarate |
| HUG116 tablet 245mg | Experimental | Drug: HUG116 tablet 245mgTenofovir disoproxil |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 19 to 45, healthy male subjects(at screening)
- Body weight over 55kg, in the range of calculated Ideal Body Weight ± 20%
- Subject without a hereditary problems, chronic disease and morbid symptom
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Key exclusion criteria (16 listed)
- Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
- Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- Volunteer who had hypersensitivity reaction to medicines including Tenofovir
- Volunteer who has genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance
- Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
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 |
|---|---|---|
| Viread® tablet 300mgSingle dose administration(PO) in the fasted state | Drug | Viread ® tablet 300mg |
| HUG116 tablet 245mgSingle dose administration(PO) in the fasted state | Drug | HUG116 tablet 245mg |
Primary outcome
Area Under Curve(AUC)last of Tenofovir
Time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Maximum of concentration(Cmax) of Tenofovir
Time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
4 secondary outcomes
Area Under Curve(AUC)inf of Tenofovir
Time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
tmax of Tenofovir
Time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
t1/2β of Tenofovir
Time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Clearance/F of Tenofovir
Time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
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 12 Apr 2018.
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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.
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 Viread® tablet 300mg and HUG116 tablet 245mg in people with Healthy, run by Huons 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 4 inclusion and 16 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 12 Apr 2018. 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?
Area Under Curve(AUC)last of Tenofovir (time frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h). 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 12 Apr 2018.