HydronidonePhase 1NCT04124081
Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects
A Phase 1 study testing Hydronidone capsules& Entecavir capsules in people with Hydronidone, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
This study, by comparing the Hydronidone capsules and entecavir capsule in a single dose and steady-state dosing state of both the level of blood drug concentration, assess Hydronidone capsules and entecavir capsule for interaction。 Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hydronidone
- What is being tested?
- Hydronidone capsules& Entecavir capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2019to 13 Aug 2019
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gender: Chinese healthy male subject;
- age: 18-40 years old, with a difference of no more than 10 years;
- weight: ≥50kg; Body mass index [= weight kg/ (height m2)] ranged from 19 to 24.
- the subject (or his/her partner) has no pregnancy plan during and within 6 months after the trial and voluntarily takes effective physical contraception and has no sperm donation plan;
- before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, and I have volunteered to participate in the clinical trial. I am able to communicate well with the investigator, comply with the requirements of the whole study, and have signed a written informed consent.
Who cannot join
- have participated in any other clinical trials within the first three months of the trial;
- (preliminary) of any process may affect test security, or drug in the body of the disease, including but not limited to: heart, liver, kidney, endocrine, the digestive tract, immune system and respiratory system always or the existing system diseases (especially cardiovascular diseases including cardiovascular disease risk, any impact on drug absorption of gastrointestinal diseases (such as irritable bowel syndrome symptoms, bowel disease or inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, eczema, dermatitis, epilepsy, allergic rhinitis, asthma, etc.);
- (consultation) allergy: if there are two or more drugs, food allergy history (including experimental drugs), lactose intolerance;
- (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoximate, griseofulvin, aminopropyl, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: ampromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide); Or have used any medicines (including Chinese herbal medicines) or health supplements within 14 days prior to initial administration;
- (consultation) have special requirements on food and cannot follow a uniform diet (such as intolerance to standard meals) or have difficulty swallowing;
- (consultation) unable to tolerate venipuncture and/or having a history of blood or acupuncture;
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- (consultation) patients who have been drinking excessive amounts of tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup =250mL) for a long time; Or taking any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first administration of the drug;
- (consultation) previous binge drinking (i.e., male drinking more than 28 units per week and female drinking more than 21 units per week (1 unit contains 14g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or who had regularly consumed alcohol (more than 14 units per week) during the 6 months prior to the trial; Or who had taken any alcoholic product within 24 hours of initial administration;
- (consultation) those who had donated blood or suffered massive bleeding (greater than 450 mL) within 3 months before the first administration of the study, or who planned to donate blood or blood components during the study period or within 3 months after the end of the study;
- (consultation) acute disease during the screening phase before study or before study medication;
- (consultation) patients who had taken food or drinks containing enzymes that can induce or inhibit liver metabolism (e.g., grapefruit, mango, pitaya, grape juice, orange juice, etc., rich in flavonoids or citrus glycosides) within 24 hours before the first administration were studied;
- (consultation) those who have had surgery within three months before the screening period, or who are planning to have surgery during the study period, and those who have had surgery that will affect drug absorption, distribution, metabolism and excretion;
- (consultation) previous history of drug abuse; A history of drug abuse;
- (consultation) those who have smoked more than 5 cigarettes per day in the 14 days before screening, or who cannot stop using any tobacco products during the trial;
- screening for smoking or using any tobacco products up to admission;
- screening phase physical examination, measurement of vital signs, electrocardiogram examination, laboratory examination [blood routine, urine routine, blood biochemistry, blood coagulation function], and the investigator judged abnormal patients with clinical significance;
- those with positive nicotine test results;
- alcohol breath test with test results greater than 0.0mg/100ml;
- positive urine drug screening;
- hepatitis b surface antigen positive, or hepatitis c antibody positive, or syphilis spirochete antibody positive, or HIV antibody positive;
- the investigator considers that there are any circumstances that may affect the subject's informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Ethics committee of drug clinical trials of huazhong university of science and technology
Wuhan, Hubei, 430030
About this study
Official title: Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects(Single Center, Single Arm, Open, Self - Control)
This study, by comparing the Hydronidone capsules and entecavir capsule in a single dose and steady-state dosing state of both the level of blood drug concentration, assess Hydronidone capsules and entecavir capsule for interaction。
- Conditions
- Hydronidone
- Being tested
- Hydronidone capsules& Entecavir capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone capsules& Entecavir capsulesDrug
take the Hydronidone capsule and then the entecavir capsule, and then take the last two together
| Study group | Role | What they receive |
|---|---|---|
| Drug group | Experimental | Not described Receives: Drug: Hydronidone capsules& Entecavir capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentration
Compare the difference in plasma drug concentration between single drug and two drug combinations
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start15 May 2019
- Primary completion15 Jun 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronidoneStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124081
- Sponsor's protocol ID
- GNI-F351-201503
- Status last verified
- Apr 2019
- First submitted
- 9 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects(Single Center, Single Arm, Open, Self - Control)
- ClinicalTrials.gov ID
- NCT04124081
- Acronym / sponsor ID
- GNI-F351-201503
- Conditions
- Hydronidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- 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.
This study, by comparing the Hydronidone capsules and entecavir capsule in a single dose and steady-state dosing state of both the level of blood drug concentration, assess Hydronidone capsules and entecavir capsule for interaction。
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug group | Experimental | Drug: Hydronidone capsules& Entecavir capsules |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- gender: Chinese healthy male subject;
- age: 18-40 years old, with a difference of no more than 10 years;
- weight: ≥50kg; Body mass index [= weight kg/ (height m2)] ranged from 19 to 24.
- the subject (or his/her partner) has no pregnancy plan during and within 6 months after the trial and voluntarily takes effective physical contraception and has no sperm donation plan;
- before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, and I have volunteered to participate in the clinical trial. I am able to communicate well with the investigator, comply with the requirements of the whole study, and have signed a written informed consent.
Key exclusion criteria (21 listed)
- have participated in any other clinical trials within the first three months of the trial;
- (preliminary) of any process may affect test security, or drug in the body of the disease, including but not limited to: heart, liver, kidney, endocrine, the digestive tract, immune system and respiratory system always or the existing system diseases (especially cardiovascular diseases including cardiovascular disease risk, any impact on drug absorption of gastrointestinal diseases (such as irritable bowel syndrome symptoms, bowel disease or inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, eczema, dermatitis, epilepsy, allergic rhinitis, asthma, etc.);
- (consultation) allergy: if there are two or more drugs, food allergy history (including experimental drugs), lactose intolerance;
- (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoximate, griseofulvin, aminopropyl, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: ampromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide); Or have used any medicines (including Chinese herbal medicines) or health supplements within 14 days prior to initial administration;
- (consultation) have special requirements on food and cannot follow a uniform diet (such as intolerance to standard meals) or have difficulty swallowing;
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 |
|---|---|---|
| Hydronidone capsules& Entecavir capsulestake the Hydronidone capsule and then the entecavir capsule, and then take the last two together | Drug | Drug group |
Primary outcome
Plasma drug concentration
Time frame: up to 12 weeks
Compare the difference in plasma drug concentration between single drug and two drug combinations
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 11 Oct 2019.
Related trials for Hydronidone
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A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.
Liver Fibrosis, Liver Fibrosis in Chronic Hepatitis B
RecruitingPhase 3
Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
Liver Fibrosis
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 Hydronidone capsules& Entecavir capsules in people with Hydronidone, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
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 21 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 11 Oct 2019. 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 China. 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?
Plasma drug concentration (time frame: up to 12 weeks). 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 11 Oct 2019.