Effect of Pharmacokinetics in Healthy Chinese Subjects

June 24, 2025 updated by: Shanghai Vinnerna Biosciences Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Zhengzhou Sixth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age: 18 years old ≤ age ≤ 45 years old; Gender is not limited;
  2. Weight: male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) in the range of 19-26 kg/m2 (including 19 and 26);
  3. Good health status, that is, vital signs, physical examination, laboratory tests, electrocardiogram and ultrasound examination are normal or abnormal and have no clinical significance;
  4. Participants who were able to take effective contraceptive measures during the study and within 3 months after the last dose of investigational product;
  5. 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.

Exclusion Criteria:

  1. Known history of allergy to the test preparation and any of its components or related preparations;
  2. Subjects with allergic diseases or allergic constitutions;
  3. 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.);
  4. Those who have donated blood or lost blood ≥ 400 mL within 3 months before enrollment, or have a history of blood product use;
  5. Those who have participated in clinical trials of other drugs and taken experimental drugs within 3 months before enrollment;
  6. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 2 weeks before screening;
  7. Those who have used any vaccine within 2 weeks prior to screening.
  8. 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;
  9. Those with a history of drug dependence or abuse within 1 year before screening, or a positive urine drug screening test;
  10. Those who have used P-gp or BCRP strong inhibitors within 2 weeks before screening (see Annex 6 of Section 10.6 for details);
  11. 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;
  12. 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);
  13. Those who smoked cigarettes within 1 year before screening, and smoked more than 10 cigarettes or the same amount of tobacco per day;
  14. Those who cannot quit smoking or alcohol during the trial;
  15. Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), treponemal antibody and HIV antibody positive;
  16. Chest X-ray (positive and lateral view) results are abnormal and clinically significant;
  17. At screening or baseline alanine aminotransferase (ALT) or glutamate aminotransferase (AST) exceeding the upper limit of normal (ULN);
  18. Glomerular filtration rate (eGFR) at screening or baseline < 80 mL/min/1.73m2;
  19. 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;
  20. Pregnant or lactating women or male subjects' spouses who have childcare plans within 3 months;
  21. Those who have other factors that the investigator believes are not suitable for participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets
Drug: Mindeudesivir hydrobromide tablets and Clarithromycin tablets
Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10.
Drug: Mindeudesivir hydrobromide tablets and Cyclosporine softgels
Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4.
Experimental: The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets
Drug: Mindeudesivir hydrobromide tablets and Clarithromycin tablets
Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10.
Drug: Mindeudesivir hydrobromide tablets and Cyclosporine softgels
Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At pre-defined intervals up to 14 days
Maximum Plasma Concentration (Cmax) of 116-N1
Time Frame: At pre-defined intervals up to 14 days
Maximum Plasma Concentration (Cmax) of 116-N1
At pre-defined intervals up to 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Half-life(T1/2) of 116-N1
Time Frame: At pre-defined intervals up to 14 days
Half-life(T1/2) of 116-N1
At pre-defined intervals up to 14 days
Clearance(CL) of 116-N1
Time Frame: At pre-defined intervals up to 14 days
Clearance(CL) of 116-N1
At pre-defined intervals up to 14 days
Tmax of 116-N1
Time Frame: At pre-defined intervals up to 14 days
Peak time of 116-N1
At pre-defined intervals up to 14 days
Vz/F of 116-N1
Time Frame: At pre-defined intervals up to 14 days
Apparent volume of distribution of 116-N1
At pre-defined intervals up to 14 days
Incidence and severity of adverse events including serious adverse events
Time Frame: Up to 18 days
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Up to 18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Vinnerna Biosciences Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shuang Li, Zhengzhou Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JT001-018-I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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