The Effects of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese SubjectsPhase 1NCT06005714
Effect of Pharmacokinetics in Healthy Chinese Subjects
A Phase 1 study testing Mindeudesivir hydrobromide tablets and Clarithromycin tablets and Mindeudesivir hydrobromide tablets and Cyclosporine softgels in people with The Effects of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open label, self-controlled phase I clinical study, to evaluate the effects of clarithromycin or cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- The Effects of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects
- What is being tested?
- Mindeudesivir hydrobromide tablets and Clarithromycin tablets and Mindeudesivir hydrobromide tablets and Cyclosporine softgels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 31 Oct 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 years old ≤ age ≤ 45 years old; Gender is not limited;
- Weight: male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) in the range of 19-26 kg/m2 (including 19 and 26);
- Good health status, that is, vital signs, physical examination, laboratory tests, electrocardiogram and ultrasound examination are normal or abnormal and have no clinical significance;
- Participants who were able to take effective contraceptive measures during the study and within 3 months after the last dose of investigational product;
- Participants who could fully understand the purpose, content and possible adverse reactions of this study, voluntarily participate in the clinical study and sign the written informed consent form, and were able to complete the entire study process and comply with the study regulations in accordance with the requirements of the study.
Who cannot join
- Known history of allergy to the test preparation and any of its components or related preparations;
- Subjects with allergic diseases or allergic constitutions;
- Those who have clear diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc., and require medical intervention or other diseases that are not suitable for participating in clinical trials (such as psychiatric history, etc.);
- Those who have donated blood or lost blood ≥ 400 mL within 3 months before enrollment, or have a history of blood product use;
- Those who have participated in clinical trials of other drugs and taken experimental drugs within 3 months before enrollment;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 2 weeks before screening;
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- Those who have used any vaccine within 2 weeks prior to screening.
- Those who have previously undergone surgery (such as major gastrectomy surgery) that may affect drug absorption, distribution, metabolism, or excretion, or may have surgery or hospitalization plans during the estimated test;
- Those with a history of drug dependence or abuse within 1 year before screening, or a positive urine drug screening test;
- Those who have used P-gp or BCRP strong inhibitors within 2 weeks before screening (see Annex 6 of Section 10.6 for details);
- Those who have ingested grapefruit juice/grapefruit juice, foods or drinks rich in methylxanthines (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours before administration, or strenuous exercise and other factors that affect drug absorption, distribution, metabolism, excretion and other factors;
- Alcohol addict within 1 year prior to screening, drinking at least 2 times a day or more than 14 units per week, or keen on alcoholism (1 unit≈ 200 mL of beer with 5% alcohol or 25 mL of spirits with 40% alcohol or 85 mL of wine with 12% alcohol);
- Those who smoked cigarettes within 1 year before screening, and smoked more than 10 cigarettes or the same amount of tobacco per day;
- Those who cannot quit smoking or alcohol during the trial;
- Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), treponemal antibody and HIV antibody positive;
- Chest X-ray (positive and lateral view) results are abnormal and clinically significant;
- At screening or baseline alanine aminotransferase (ALT) or glutamate aminotransferase (AST) exceeding the upper limit of normal (ULN);
- Glomerular filtration rate (eGFR) at screening or baseline < 80 mL/min/1.73m2;
- Abnormal ECG at screening or baseline, a single QTcF (mean of QT interval corrected by Fridericia formula) > 450 ms for men and 470 ms >for women, and/or other abnormalities of clinical significance;
- Pregnant or lactating women or male subjects' spouses who have childcare plans within 3 months;
- Those who have other factors that the investigator believes are not suitable for participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects
This study is a single-center, open label, self-controlled phase I clinical study, to evaluate the effects of clarithromycin or cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets in healthy Chinese subjects.
- Being tested
- Mindeudesivir hydrobromide tablets and Clarithromycin tablets, Mindeudesivir hydrobromide tablets and Cyclosporine softgels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindeudesivir hydrobromide tablets and Clarithromycin tabletsDrug
Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10.
Mindeudesivir hydrobromide tablets and Cyclosporine softgelsDrug
Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4.
| Study group | Role | What they receive |
|---|---|---|
| The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets | Experimental | Not described Receives: Drug: Mindeudesivir hydrobromide tablets and Clarithromycin tablets; Drug: Mindeudesivir hydrobromide tablets and Cyclosporine softgels |
| The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets | Experimental | Not described Receives: Drug: Mindeudesivir hydrobromide tablets and Clarithromycin tablets; Drug: Mindeudesivir hydrobromide tablets and Cyclosporine softgels |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t of 116-N1
Area under the curve from time zero to the time of the t(AUC0-t ) of 116-N1
Measured: At pre-defined intervals up to 14 days
Maximum Plasma Concentration (Cmax) of 116-N1
Maximum Plasma Concentration (Cmax) of 116-N1
Measured: At pre-defined intervals up to 14 days
Secondary outcomes (5)
Half-life(T1/2) of 116-N1
Half-life(T1/2) of 116-N1
Measured: At pre-defined intervals up to 14 days
Clearance(CL) of 116-N1
Clearance(CL) of 116-N1
Measured: At pre-defined intervals up to 14 days
Tmax of 116-N1
Peak time of 116-N1
Measured: At pre-defined intervals up to 14 days
Vz/F of 116-N1
Apparent volume of distribution of 116-N1
Measured: At pre-defined intervals up to 14 days
Incidence and severity of adverse events including serious adverse events
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effects of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese SubjectsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuang Li, Principal investigator, The Sixth People's Hospital of Zhengzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005714
- Sponsor's protocol ID
- JT001-018-I
- Status last verified
- Jun 2025
- First submitted
- 15 Aug 2023
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06005714
- Acronym / sponsor ID
- JT001-018-I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Aug 2023 (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 is a single-center, open label, self-controlled phase I clinical study, to evaluate the effects of clarithromycin or cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets in healthy Chinese subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets | Experimental | Drug: Mindeudesivir hydrobromide tablets and Clarithromycin tablets, Drug: Mindeudesivir hydrobromide tablets and Cyclosporine softgels |
| The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets | Experimental | Drug: Mindeudesivir hydrobromide tablets and Clarithromycin tablets, Drug: Mindeudesivir hydrobromide tablets and Cyclosporine softgels |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 years old ≤ age ≤ 45 years old; Gender is not limited;
- Weight: male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) in the range of 19-26 kg/m2 (including 19 and 26);
- Good health status, that is, vital signs, physical examination, laboratory tests, electrocardiogram and ultrasound examination are normal or abnormal and have no clinical significance;
- Participants who were able to take effective contraceptive measures during the study and within 3 months after the last dose of investigational product;
- Participants who could fully understand the purpose, content and possible adverse reactions of this study, voluntarily participate in the clinical study and sign the written informed consent form, and were able to complete the entire study process and comply with the study regulations in accordance with the requirements of the study.
Key exclusion criteria (21 listed)
- Known history of allergy to the test preparation and any of its components or related preparations;
- Subjects with allergic diseases or allergic constitutions;
- Those who have clear diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc., and require medical intervention or other diseases that are not suitable for participating in clinical trials (such as psychiatric history, etc.);
- Those who have donated blood or lost blood ≥ 400 mL within 3 months before enrollment, or have a history of blood product use;
- Those who have participated in clinical trials of other drugs and taken experimental drugs within 3 months before enrollment;
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 |
|---|---|---|
| Mindeudesivir hydrobromide tablets and Clarithromycin tabletsMindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10. | Drug | The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets, The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets |
| Mindeudesivir hydrobromide tablets and Cyclosporine softgelsMindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4. | Drug | The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets, The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets |
Primary outcome
AUC0-t of 116-N1
Time frame: At pre-defined intervals up to 14 days
Area under the curve from time zero to the time of the t(AUC0-t ) of 116-N1
Maximum Plasma Concentration (Cmax) of 116-N1
Time frame: At pre-defined intervals up to 14 days
Maximum Plasma Concentration (Cmax) of 116-N1
5 secondary outcomes
Half-life(T1/2) of 116-N1
Time frame: At pre-defined intervals up to 14 days
Clearance(CL) of 116-N1
Time frame: At pre-defined intervals up to 14 days
Tmax of 116-N1
Time frame: At pre-defined intervals up to 14 days
Vz/F of 116-N1
Time frame: At pre-defined intervals up to 14 days
Incidence and severity of adverse events including serious adverse events
Time frame: Up to 18 days
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 29 Jun 2025.
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.
Shuang Li principal investigator
The Sixth People's Hospital of Zhengzhou
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 Mindeudesivir hydrobromide tablets and Clarithromycin tablets and Mindeudesivir hydrobromide tablets and Cyclosporine softgels in people with The Effects of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects, run by Shanghai Vinnerna Biosciences 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 29 Jun 2025. 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?
AUC0-t of 116-N1 (time frame: At pre-defined intervals up to 14 days). 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 29 Jun 2025.