HealthyNCT04125056
Study on Hydronidone Capsule BE
A study testing Hydronidone Capsule(Specification: 30 mg / grain） and Hydronidone Capsule(Specification: 15 mg / grain） in people with Healthy, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
The purpose of this study was to compare the hydronidone capsules (specification: 30 mg/particle, test preparation) developed by Shanghai Ruixing Gene Technology corporation with Self reference preparation hydronidone capsule (specification: 15 mg/capsule) Differences in the extent and rate of absorption of healthy… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hydronidone Capsule(Specification: 30 mg / grain） and Hydronidone Capsule(Specification: 15 mg / grain）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2019to 4 Mar 2019
- Phase
- Interventional
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: Chinese healthy male subjects;
- Age: 18 to 65 years old, including 18 and 65 years old;
- Weight should not be less than 50 kg, body mass index (BMI) in the range of 19 to 26 (including the boundary value) ((BMI) = weight (kg) / height 2 (m2));
- The subject (or his or her partner) has no pregnancy plan during the trial period and 6 months after the end of the trial and voluntarily adopts effective physical contraception and has no sperm donation or egg donation plan;
- Before the trial, you have a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential risks, and volunteered to participate in this clinical trial, to communicate well with the researchers, to comply with the requirements of the entire study, and to sign the written Informed consent.
Who cannot join
- (Questions) There are any diseases that may affect the safety of the test or the in vivo process of the drug, including but not limited to: liver, kidney, endocrine, cardiovascular, digestive, neurological, mental, respiratory, neoplastic, immune, skin, blood or Researchers of metabolic systems think that it is not suitable for the past medical history or existing medical history of the test [especially those with cardiovascular disease including cardiovascular disease risk, any gastrointestinal diseases affecting drug absorption (such as irritable bowel syndrome symptoms, bowel) History of disease or inflammatory bowel disease), active pathological hemorrhage (such as peptic ulcer), urticaria, epilepsy, asthma, etc. or other diseases that are not suitable for clinical trials;
- (Questions)allergies: such as those who are allergic to two or more drugs, food; lactose intolerance;
- (Questions)Any drug that inhibits or induces liver metabolism of the drug within 28 days prior to taking the study drug (common liver enzyme inducer: barbiturate (the most common phenobarbital), carbamazepine, ammonia Mitt, griseofulvin, methamphetamine, phenytoin, glutamine, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole Oxazole, chloramphenicol, isoniazid, sulfa drug); or any drug (including Chinese herbal medicine) and health care products used within 14 days before the first dose;
- (Questions) have special requirements for food, can not comply with a unified diet (such as intolerance to standard foods) or have difficulty swallowing;
- (Questions)Can not tolerate venipuncture and / or have a history of halo, fainting;
- (Questions)Overdose (over 8 cups a day, 1 cup = 250mL) tea, coffee or caffeinated beverages during the first three months of screening; or take any caffeine and jaundice from the screening to -1 day admission Food or beverage (such as coffee, tea, chocolate, etc.) and other special dieters that affect the absorption, distribution, metabolism, and excretion of drugs;
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- (Questions)Drinking more than 14 standard units per week for the first 3 months of screening (1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); or no alcohol during the test period Or study any alcohol-containing product within 24 hours prior to the first administration, and the result of the alcohol breath test is greater than 0.0 mg/100 mL;
- (Questions)Studying blood donation within 3 months prior to the first dose, including component blood or massive bleeding (greater than 450 mL), or planning to donate blood or blood components during the study period or within 3 months after the end of the study;
- (Questions)Acute disease occurs prior to the pre-study screening phase or prior to study medication;
- (Questions)Screened to a food or drink containing inducible or inhibited liver metabolic enzymes (such as grapefruit, mango, dragon fruit, grape juice, orange juice and other flavonoids or citrus glycosides) during admission;
- (Questions)Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study period, and those who have received surgery that affect drug absorption, distribution, metabolism, and excretion;
- (Questions)History of drug abuse, history of drug abuse; positive urine screening;
- (Questions)The number of cigarettes per day for the first 3 months of screening is greater than 5, or no tobacco products can be stopped during the trial; those who smoked or used any tobacco products during the screening period, and those with positive nicotine tests;
- Physical examination during screening, vital sign measurement, electrocardiogram examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), the investigator judged that the abnormality has clinical significance;
- Hepatitis B surface antigen positive, or hepatitis C antibody positive, or syphilis antibody positive, or HIV antibody positive;
- Those who have participated in any other clinical trials within 3 months prior to the trial;
- The investigator believes that there are any circumstances that may affect the subject's informed consent or follow the protocol, or participate in the trial that may affect the outcome of the trial or its own safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Test of Hydronidone Capsules in the Hollow Abdominal State of Chinese Healthy Volunteers
The purpose of this study was to compare the hydronidone capsules (specification: 30 mg/particle, test preparation) developed by Shanghai Ruixing Gene Technology corporation with Self reference preparation hydronidone capsule (specification: 15 mg/capsule) Differences in the extent and rate of absorption of healthy male subjects in Fasting state in China. Through the main pharmacokinetic parameters and relative bioavailability, whether the two are bioequivalent, and provide a basis for the registration of the test preparation
- Conditions
- Healthy
- Being tested
- Hydronidone Capsule(Specification: 30 mg / grain）, Hydronidone Capsule(Specification: 15 mg / grain）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone Capsule(Specification: 30 mg / grain）Drug
Test group
Hydronidone Capsule(Specification: 15 mg / grain）Drug
Control group
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Hydronidone capsules (Specification: 30 mg / capsule） Receives: Drug: Hydronidone Capsule(Specification: 30 mg / grain） |
| Control group | Placebo comparator | Hydronidone capsules (Specification: 15 mg / capsule） Receives: Drug: Hydronidone Capsule(Specification: 15 mg / grain） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: up to 12 weeks
AUC
Measured: up to 12 weeks
Tmax
Measured: up to 12 weeks
Secondary outcomes (1)
λz
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 posted14 Oct 2019
- Study start16 Jan 2019
- Primary completion23 Jan 2019
- Study completion4 Mar 2019
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04125056
- Sponsor's protocol ID
- GNI-F351-1801
- Status last verified
- Feb 2019
- First submitted
- 9 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Test of Hydronidone Capsules in the Hollow Abdominal State of Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04125056
- Acronym / sponsor ID
- GNI-F351-1801
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 14 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.
The purpose of this study was to compare the hydronidone capsules (specification: 30 mg/particle, test preparation) developed by Shanghai Ruixing Gene Technology corporation with Self reference preparation hydronidone capsule (specification: 15 mg/capsule) Differences in the extent and rate of absorption of healthy male subjects in Fasting state in China. Through the main pharmacokinetic parameters and relative bioavailability, whether the two are bioequivalent, and provide a basis for the registration of the test preparation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Hydronidone Capsule(Specification: 30 mg / grain）Hydronidone capsules (Specification: 30 mg / capsule） |
| Control group | Placebo comparator | Drug: Hydronidone Capsule(Specification: 15 mg / grain）Hydronidone capsules (Specification: 15 mg / capsule） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gender: Chinese healthy male subjects;
- Age: 18 to 65 years old, including 18 and 65 years old;
- Weight should not be less than 50 kg, body mass index (BMI) in the range of 19 to 26 (including the boundary value) ((BMI) = weight (kg) / height 2 (m2));
- The subject (or his or her partner) has no pregnancy plan during the trial period and 6 months after the end of the trial and voluntarily adopts effective physical contraception and has no sperm donation or egg donation plan;
- Before the trial, you have a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential risks, and volunteered to participate in this clinical trial, to communicate well with the researchers, to comply with the requirements of the entire study, and to sign the written Informed consent.
Key exclusion criteria (17 listed)
- (Questions) There are any diseases that may affect the safety of the test or the in vivo process of the drug, including but not limited to: liver, kidney, endocrine, cardiovascular, digestive, neurological, mental, respiratory, neoplastic, immune, skin, blood or Researchers of metabolic systems think that it is not suitable for the past medical history or existing medical history of the test [especially those with cardiovascular disease including cardiovascular disease risk, any gastrointestinal diseases affecting drug absorption (such as irritable bowel syndrome symptoms, bowel) History of disease or inflammatory bowel disease), active pathological hemorrhage (such as peptic ulcer), urticaria, epilepsy, asthma, etc. or other diseases that are not suitable for clinical trials;
- (Questions)allergies: such as those who are allergic to two or more drugs, food; lactose intolerance;
- (Questions)Any drug that inhibits or induces liver metabolism of the drug within 28 days prior to taking the study drug (common liver enzyme inducer: barbiturate (the most common phenobarbital), carbamazepine, ammonia Mitt, griseofulvin, methamphetamine, phenytoin, glutamine, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole Oxazole, chloramphenicol, isoniazid, sulfa drug); or any drug (including Chinese herbal medicine) and health care products used within 14 days before the first dose;
- (Questions) have special requirements for food, can not comply with a unified diet (such as intolerance to standard foods) or have difficulty swallowing;
- (Questions)Can not tolerate venipuncture and / or have a history of halo, fainting;
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 Capsule(Specification: 30 mg / grain）Test group | Drug | test group |
| Hydronidone Capsule(Specification: 15 mg / grain）Control group | Drug | Control group |
Primary outcome
Cmax
Time frame: up to 12 weeks
AUC
Time frame: up to 12 weeks
Tmax
Time frame: up to 12 weeks
1 secondary outcome
λz
Time frame: up to 12 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 14 Oct 2019.
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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 study testing Hydronidone Capsule(Specification: 30 mg / grain） and Hydronidone Capsule(Specification: 15 mg / grain） in people with Healthy, 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 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 14 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cmax (time frame: up to 12 weeks). The study lists 3 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 14 Oct 2019.