A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension

NCT06749236 | Completed Phase 1

• 1 other identifier: VV116-RSV-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Cmax

  maximum observed plasma concentration

  48 hours after administration

• AUC0-t

  area under the plasma concentration time curve from time zero to the last measurable concentration

  48 hours after administration

• AUC0-∞

  area under the plasma concentration-time curve from time zero to infinity

  48 hours after administration]

Secondary Outcomes (9)

• AUC0-24h

  24 hours after administration

• Tmax

  48 hours after administration

• Tlag

  48 hours after administration

• t1/2

  48 hours after administration

• CLz/F

  48 hours after administration

Study Arms (2)

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.

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.

Drug: test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension; Drug: reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension

Interventions

test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension DRUG

Participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).

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 suspension DRUG

Participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).

reference formulation (R) then test formulation(T) deuteriumremidvir hydrobromide for suspension; test formulation(T) then reference formulation (R) of deuteriumremidvir hydrobromide for suspension

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Xuzhou, Jiangsu, 233004, China

Location

MeSH Terms

Interventions

Suspensions

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: August 11, 2025
• Primary Completion: August 20, 2025
• Study Completion: September 3, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)