Healthy ParticipantsPhase 1NCT06749236
A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension
A Phase 1 study testing test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension and reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension in people with Healthy Participants, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
The goal of this clinical study is to evaluate the bioavailability of two specifications of oral Deuteriumremidvir Hydrobromide for suspension in Chinese healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension and reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 3 Sep 2025
- 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
- Aged 18 to 45 years old, males or females;
- Male weight no less than 50 kg, female weight no less than 45 kg, body mass Index of 19 to 26 kg/m^2;
- Vital signs examination, physical examination, laboratory examination and electrocardiogram examination results were normal or considered abnormal without clinical significance by the investigator;
- Subjects who are willing to take proper contraceptive during the study and within 3 months after the the last administration;
- Subjects who are able to understand and follow the study protocol and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
Who cannot join
- Participants with hypersensitivity to deuremidevir hydrobromide for suspension or any of the excipients;
- Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
- Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
- Participants who undergone surgery within 3 months before screening, or are planning to operate during the trial, or those who have undergone surgery that will affect the absorption, distribution, metabolism or excretion of drugs;
- Participants who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (except female physiological blood loss);
- Participants who have participated in clinical trials of other drugs and received drugs within 90 days before screening;
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- Participants who have received vaccination within the first 1 month before screening, or planned to receive any vaccine during the trial or within 1 week after the end of the study；
- Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products orally within 2 weeks before screening;
- Participants who have eaten grapefruits, pomelos, oranges, etc. within 7 days before screening, or do not agree to stop consuming the above fruits and drinks during the period;
- Participants with a history of drug abuse within 1 year before screening or positive urine drug screening within 1 year before screening results (morphine, THC, methamphetamine, dimethylene diphetamine, ketamine, and cocaine);
- Participants who drinking more than 14 standard units per week within one year before screening,(one standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of strong liquor with 40% alcohol content or 150 mL of wine), or being positive in the alcohol breath tests;
- Participants who smoked more than 5 cigarettes a day within one year before screening;
- Participants who can't quit smoking or drinking during the trial period;
- Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV);
- Abnormal chest X-ray results with clinical significance;
- Abnormal ECG at screening or baseline, including QTcF (after heart rate correction) is >450 ms for males and > 470 ms for females in single examinations, and/or other abnormalities with clinical significance;
- Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting with dizzy needle;
- Participants who cannot comply with a uniform diet (such as special dietary requirements, intolerance of standard meals, etc.), or be with lactose intolerance, or dysphagia;
- Pregnant or lactating women or male participants whose spouse has a child care plan within 3 months;
- The investigator believes that there are other unsuitable factors for this volunteer to participate this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical College
Xuzhou, Jiangsu, 233004
About this study
Official title: A Single-center, Randomized, Open-label, Two-period, Crossover Clinical Study to Evaluate the Bioavailability of Two Specifications of Oral Deuterium Deuremidevir for Hydrobromide Suspension in Chinese Healthy Adult Participants
The goal of this clinical study is to evaluate the bioavailability of two specifications of oral Deuteriumremidvir Hydrobromide for suspension in Chinese healthy adult participants. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
Read the detailed description
This is a single-center, randomized, open-label, two-period, crossover clinical study to evaluate the bioavailability of two specifications of oral deuteriumremidvir hydrobromide for suspension. With a washout period of 3 days, the dose is 200 mg in each sequence. The specification of the test formulation(T) is 200 mg and that for the reference formulation (R) is 100 mg. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
- Conditions
- Healthy Participants
- Being tested
- test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension, reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspensionDrug
Participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).
reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspensionDrug
Participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).
| Study group | Role | What they receive |
|---|---|---|
| test formulation(T) then reference formulation (R) of deuteriumremidvir hydrobromide for suspension | Experimental | On day 1 of the 1st period, participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension), and on day 1 of the 2nd period, participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).The two periods are separated by a washout of 3 days. Receives: Drug: test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension; Drug: reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension |
| reference formulation (R) then test formulation(T) deuteriumremidvir hydrobromide for suspension | Experimental | On day 1 of the 1st period, participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension), and on day 1 of the 2nd period, participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).The two periods are separated by a washout of 3 days. Receives: Drug: test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension; Drug: reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed plasma concentration
Measured: 48 hours after administration
AUC0-t
area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: 48 hours after administration
AUC0-∞
area under the plasma concentration-time curve from time zero to infinity
Measured: 48 hours after administration]
Secondary outcomes (9)
AUC0-24h
area under the plasma concentration-time curve from 0 to 24 hours
Measured: 24 hours after administration
Tmax
time at which Cmax occurs
Measured: 48 hours after administration
Tlag
time lag
Measured: 48 hours after administration
t1/2
half life of elimination
Measured: 48 hours after administration
CLz/F
apparent clearance
Measured: 48 hours after administration
Vz/F
apparent volume of distribution during the terminal phase
Measured: 48 hours after administration
λz
first-order rate constant associated with the terminal (log-linear) portion of the curve
Measured: 48 hours after administration
MRT
mean residence time
Measured: 48 hours after administration
AE & SAE
Adverse event \& serious adverse events
Measured: from day1 to day6 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start11 Aug 2025
- Primary completion20 Aug 2025
- Study completion3 Sep 2025
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.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749236
- Sponsor's protocol ID
- VV116-RSV-03
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2024
- Last updated
- 21 Nov 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Two-period, Crossover Clinical Study to Evaluate the Bioavailability of Two Specifications of Oral Deuterium Deuremidevir for Hydrobromide Suspension in Chinese Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06749236
- Acronym / sponsor ID
- VV116-RSV-03
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 27 Dec 2024 (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 goal of this clinical study is to evaluate the bioavailability of two specifications of oral Deuteriumremidvir Hydrobromide for suspension in Chinese healthy adult participants. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
Detailed description
This is a single-center, randomized, open-label, two-period, crossover clinical study to evaluate the bioavailability of two specifications of oral deuteriumremidvir hydrobromide for suspension. With a washout period of 3 days, the dose is 200 mg in each sequence. The specification of the test formulation(T) is 200 mg and that for the reference formulation (R) is 100 mg. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test formulation(T) then reference formulation (R) of deuteriumremidvir hydrobromide for suspension | Experimental | Drug: test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension, Drug: reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspensionOn day 1 of the 1st period, participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension), and on day 1 of the 2nd period, participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).The two periods are separated by a washout of 3 days. |
| reference formulation (R) then test formulation(T) deuteriumremidvir hydrobromide for suspension | Experimental | Drug: test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension, Drug: reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspensionOn day 1 of the 1st period, participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension), and on day 1 of the 2nd period, participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).The two periods are separated by a washout of 3 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 45 years old, males or females;
- Male weight no less than 50 kg, female weight no less than 45 kg, body mass Index of 19 to 26 kg/m^2;
- Vital signs examination, physical examination, laboratory examination and electrocardiogram examination results were normal or considered abnormal without clinical significance by the investigator;
- Subjects who are willing to take proper contraceptive during the study and within 3 months after the the last administration;
- Subjects who are able to understand and follow the study protocol and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
Key exclusion criteria (20 listed)
- Participants with hypersensitivity to deuremidevir hydrobromide for suspension or any of the excipients;
- Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
- Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
- Participants who undergone surgery within 3 months before screening, or are planning to operate during the trial, or those who have undergone surgery that will affect the absorption, distribution, metabolism or excretion of drugs;
- Participants who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (except female physiological blood loss);
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 |
|---|---|---|
| test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspensionParticipants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension). | Drug | reference formulation (R) then test formulation(T) deuteriumremidvir hydrobromide for suspension, test formulation(T) then reference formulation (R) of deuteriumremidvir hydrobromide for suspension |
| reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspensionParticipants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension). | Drug | reference formulation (R) then test formulation(T) deuteriumremidvir hydrobromide for suspension, test formulation(T) then reference formulation (R) of deuteriumremidvir hydrobromide for suspension |
Primary outcome
Cmax
Time frame: 48 hours after administration
maximum observed plasma concentration
AUC0-t
Time frame: 48 hours after administration
area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-∞
Time frame: 48 hours after administration]
area under the plasma concentration-time curve from time zero to infinity
9 secondary outcomes
AUC0-24h
Time frame: 24 hours after administration
Tmax
Time frame: 48 hours after administration
Tlag
Time frame: 48 hours after administration
t1/2
Time frame: 48 hours after administration
CLz/F
Time frame: 48 hours after administration
Vz/F
Time frame: 48 hours after administration
λz
Time frame: 48 hours after administration
MRT
Time frame: 48 hours after administration
AE & SAE
Time frame: from day1 to day6 after administration
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 21 Nov 2025.
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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.
Huan Zhou principal investigator
The First Affiliated Hospital of Bengbu Medical 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 test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension and reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension in people with Healthy Participants, run by Vigonvita Life Sciences 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 20 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 21 Nov 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?
Cmax (time frame: 48 hours after administration). 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 21 Nov 2025.