Healthy ParticipantsPhase 1NCT07510529
A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adults
A Phase 1 study testing T-R (Test-Reference drug) and R-T (Reference-Test drug) in people with Healthy Participants, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- T-R (Test-Reference drug) and R-T (Reference-Test drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to 30 Aug 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read, understand, voluntarily participate, and sign the informed consent form.
- Aged 18 to 50 years (inclusive) at screening, male or female.
- 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^)].
- 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.
- 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.
- Able to communicate well with clinical staff and complete the study per protocol requirements.
Who cannot join
- 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.
- History of any condition with bleeding risk, such as acute gastritis or gastric/duodenal ulcer.
- Current history of oral ulcers, or acute or chronic infection within 1 week before screening.
- Major illness or major surgery within 3 months before screening, or anticipated major surgery during the study period.
- Blood donation or significant blood loss (>400 mL) within 3 months before screening.
- Allergic constitution (allergic to multiple foods/drugs), or known allergy to the investigational product, its components, or related products.
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- Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, HIV antigen/antibody, or Treponema pallidum antibody (TP-Ab).
- Positive pregnancy test at screening or baseline, or currently breastfeeding.
- 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.
- 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.
- 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.
- 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.
- Average weekly alcohol consumption exceeding 14 units within 3 months before screening (1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine).
- Average daily smoking >5 cigarettes or equivalent tobacco within 3 months before screening.
- History of drug abuse within 1 year before screening.
- Positive alcohol breath test or positive urine drug abuse screen at baseline.
- Unable to tolerate intravenous catheter blood collection or has a needle/blood phobia.
- 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.
- Unable to comply with standardized meals (e.g., special dietary requirements, refusal to accept standard meals).
- Occurrence of acute illness with clinical significance or use of any medication between screening and baseline.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- T-R (Test-Reference drug), R-T (Reference-Test drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-R (Test-Reference drug)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
R-T (Reference-Test drug)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
| Study group | Role | What they receive |
|---|---|---|
| SIM0916（0.2 g） | Experimental | Not described Receives: Drug: T-R (Test-Reference drug); Drug: R-T (Reference-Test drug) |
| SIM0916（0.1g） | Active comparator | Not described Receives: Drug: T-R (Test-Reference drug); Drug: R-T (Reference-Test drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
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)
Measured: From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
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)
Measured: From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
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)
Measured: From enrollment to Day10
Secondary outcomes (6)
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
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）
Measured: 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
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）
Measured: 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
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）
Measured: 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
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）
Measured: 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
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）
Measured: 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
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）
Measured: From enrollment to Day10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start17 Apr 2026
- Primary completion2 May 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaojiao Li, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510529
- Sponsor's protocol ID
- SIM0916-101
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07510529
- Acronym / sponsor ID
- SIM0916-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 3 Apr 2026 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM0916（0.2 g） | Experimental | Drug: T-R (Test-Reference drug), Drug: R-T (Reference-Test drug) |
| SIM0916（0.1g） | Active comparator | Drug: T-R (Test-Reference drug), Drug: R-T (Reference-Test drug) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to read, understand, voluntarily participate, and sign the informed consent form.
- Aged 18 to 50 years (inclusive) at screening, male or female.
- 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^)].
- 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.
- 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.
Key exclusion criteria (21 listed)
- 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.
- History of any condition with bleeding risk, such as acute gastritis or gastric/duodenal ulcer.
- Current history of oral ulcers, or acute or chronic infection within 1 week before screening.
- Major illness or major surgery within 3 months before screening, or anticipated major surgery during the study period.
- Blood donation or significant blood loss (>400 mL) within 3 months before screening.
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 |
|---|---|---|
| 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 | SIM0916（0.1g）, SIM0916（0.2 g） |
| 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 | Drug | SIM0916（0.1g）, SIM0916（0.2 g） |
Primary outcome
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)
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)
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)
6 secondary outcomes
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 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 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
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
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
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
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 23 Oct 2026.
- Individual participant dataSharing planned: No
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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.
xiaojiao Li principal investigator
The First Hospital of Jilin University
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 T-R (Test-Reference drug) and R-T (Reference-Test drug) in people with Healthy Participants, run by Simcere 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 6 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 23 Oct 2026. 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?
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (time frame: From enrollment to Day10). 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 23 Oct 2026.