A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adults

April 1, 2026 updated by: Simcere Pharmaceutical Co., Ltd

A Single-Center, Open-Label, Randomized, Two-Sequence, Two-Period Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adult Participants

A single-center, open-label, randomized, two-sequence, two-period crossover study in 48 healthy subjects to compare the relative bioavailability of two formulations. The test (T, 0.2 g/sachet) and reference (R, 0.1 g/sachet) are administered at a dose of 0.2 g per period: sequence T-R receives 1 sachet T (period 1) and 2 sachets R (period 2); sequence R-T receives 2 sachets R (period 1) and 1 sachet T (period 2). Subjects are randomized 1:1 to either sequence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

This is a single-center, open-label, randomized, two-sequence, two-period crossover study to assess the relative bioavailability of two formulations. The test product (T) is the 0.2 g/sachet formulation, and the reference product (R) is the 0.1 g/sachet formulation. The formulations are not identical. The study plans to enroll 48 healthy participants, male and female, who will be randomized in a 1:1 ratio to two dosing sequences (T-R and R-T), with 24 participants per sequence. The administered dose per period is 0.2 g for both T and R. Participants in the T-R sequence receive 1 sachet of the test product (T) in Period 1 and 2 sachets of the reference product (R) in Period 2. Participants in the R-T sequence receive 2 sachets of the reference product (R) in Period 1 and 1 sachet of the test product (T) in Period 2.

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 (Estimated)

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.
48

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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. Able to read, understand, voluntarily participate, and sign the informed consent form.
  2. Aged 18 to 50 years (inclusive) at screening, male or female.
  3. Body weight ≥50 kg for males and ≥45 kg for females, Body Mass Index (BMI) between 18 and 28 kg/m^2^ (inclusive) [BMI = weight (kg) / height^2^ (m^2^)].
  4. Vital signs, physical examination, laboratory tests, ECG, and chest X-ray (posteroanterior view) are normal or judged as abnormal without clinical significance by the investigator.
  5. Participants (including male participants) and their spouses/partners must have no pregnancy plan (including sperm/egg donation) from signing the informed consent form until at least 30 days after the last dose, and voluntarily agree to use effective contraceptive methods.
  6. Able to communicate well with clinical staff and complete the study per protocol requirements.

Exclusion Criteria:

  1. Presence of clinically significant diseases within 12 months before screening, including but not limited to digestive, circulatory, respiratory, endocrine, urinary, immune, nervous system disorders, and mental/psychological diseases.
  2. History of any condition with bleeding risk, such as acute gastritis or gastric/duodenal ulcer.
  3. Current history of oral ulcers, or acute or chronic infection within 1 week before screening.
  4. Major illness or major surgery within 3 months before screening, or anticipated major surgery during the study period.
  5. Blood donation or significant blood loss (>400 mL) within 3 months before screening.
  6. Allergic constitution (allergic to multiple foods/drugs), or known allergy to the investigational product, its components, or related products.
  7. Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, HIV antigen/antibody, or Treponema pallidum antibody (TP-Ab).
  8. Positive pregnancy test at screening or baseline, or currently breastfeeding.
  9. Screening 12-lead ECG showing QTcF ≥470 ms for males or QTcF ≥480 ms for females. QTcF = QT/[(60/HR)^0.33], where HR is heart rate.
  10. Use of prescription or non-prescription drugs (including traditional Chinese medicine and health supplements) within 14 days or 5 half-lives (whichever is longer) before screening.
  11. Vaccination with live, attenuated live, or any live virus component vaccines within 12 weeks before dosing, or planned during the study period and up to 8 weeks after the last dose.
  12. Participation in any clinical trial and receiving at least one dose of investigational product within 3 months or 5 half-lives (whichever is longer) before screening.
  13. Average weekly alcohol consumption exceeding 14 units within 3 months before screening (1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine).
  14. Average daily smoking >5 cigarettes or equivalent tobacco within 3 months before screening.
  15. History of drug abuse within 1 year before screening.
  16. Positive alcohol breath test or positive urine drug abuse screen at baseline.
  17. Unable to tolerate intravenous catheter blood collection or has a needle/blood phobia.
  18. Consumption of specific diets (including dragon fruit, mango, grapefruit, and/or xanthine-containing diet, caffeinated foods or beverages), or strenuous exercise, or consumption of any alcoholic products within 48 hours before dosing.
  19. Unable to comply with standardized meals (e.g., special dietary requirements, refusal to accept standard meals).
  20. Occurrence of acute illness with clinical significance or use of any medication between screening and baseline.
  21. Any other condition that, in the investigator's opinion, may affect the participant's ability to provide informed consent or comply with the protocol, or makes the participant unsuitable for the study, or participation may affect the study results or the participant's safety.

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: 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: SIM0916（0.2 g）
Drug: T-R (Test-Reference drug)
Participants in the T-R sequence receive 1 sachet of the test product (T) in Period 1 and 2 sachets of the reference product (R) in Period 2
Drug: R-T (Reference-Test drug)
Participants in the R-T sequence receive 2 sachets of the reference product (R) in Period 1 and 1 sachet of the test product (T) in Period 2
Active Comparator: SIM0916（0.1g）
Drug: T-R (Test-Reference drug)
Participants in the T-R sequence receive 1 sachet of the test product (T) in Period 1 and 2 sachets of the reference product (R) in Period 2
Drug: R-T (Reference-Test drug)
Participants in the R-T sequence receive 2 sachets of the reference product (R) in Period 1 and 1 sachet of the test product (T) in Period 2

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
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Time Frame: From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (C~max) of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Time Frame: From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (AUC~0-t) of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Time Frame: From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (AUC~0-∞) of the main metabolite 116-N1 after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
From enrollment to Day10

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
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Time Frame: From enrollment to Day10
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension（Cmax）（test vs. reference）
From enrollment to Day10
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Time Frame: From enrollment to Day10
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （AUC0-t）（test vs. reference）
From enrollment to Day10
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Time Frame: From enrollment to Day10
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （AUC0-∞）（test vs. reference）
From enrollment to Day10
PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Time Frame: From enrollment to Day10
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （AUC_%Extrap）（test vs. reference）
From enrollment to Day10
PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Time Frame: From enrollment to Day10
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （Tmax）（test vs. reference）
From enrollment to Day10
PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Time Frame: From enrollment to Day10
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （t1/2）（test vs. reference）
From enrollment to Day10

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.
Simcere Pharmaceutical 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: xiaojiao Li, The First hospital of Jilin University

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 (Estimated)

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.
April 20, 2026

Primary Completion (Estimated)

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.
May 31, 2026

Study Completion (Estimated)

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.
June 30, 2026

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).
March 26, 2026

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.
April 1, 2026

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.
April 3, 2026

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.
April 3, 2026

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.
April 1, 2026

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.
March 1, 2026

More Information

Terms related to this study

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.
  • SIM0916-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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