A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Dolutegravir Sodium Tablets (DTG)

NCT07002229 | Completed Phase 1

• 1 other identifier: GQ-FNC-107
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase (RdRp). This is a clinical study to evaluate the Interactions between FNC and Dolutegravir Sodium Tablets in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 5 consecutive days each cycle, and the washout period between each cycle was 7 days. Biological sample collection and safety examination were performed.

Conditions

Healthy

Keywords

Azvudine

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine and Dolutegravir

  Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.

• Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine and Dolutegravir

  Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.

• Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine and Dolutegravir

  Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.

Secondary Outcomes (1)

• Occurrence of Adverse Events

  From enrollment to the end of the study on Day 29.

Study Arms (3)

Group 1 : FNC+ DTG;FNC;DTG

EXPERIMENTAL

Drug: Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)

Group 2 : FNC; DTG; FNC+DTG

EXPERIMENTAL

Drug: Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)

Group 3 : DTG;FNC+DTG;FNC

EXPERIMENTAL

Drug: Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)

Interventions

Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG) DRUG

This study consisted of 3 cycles, each cycle was administered orally for 5 consecutive days, and the washout period between each cycle was 7 days. Subjects were administered the drug as follow: FNC+ DTG: FNC 3 mg (1 tablet) + DTG 50 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 5 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days; DTG: 50 mg (1 tablet) each time, 1 time a day, orally, for 5 consecutive days.

Group 1 : FNC+ DTG;FNC;DTG

Eligibility Criteria

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

You may qualify if:

• Healthy subjects aged ≥ 18 years old and ≤ 45 years old, regardless of gender;
• Body mass index (BMI) within the range of 19.0-26.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
• Those who had no birth plan within 2 weeks before screening and within 6 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial;
• Understand and sign the informed consent form.

You may not qualify if:

• Persons with allergic constitutions, history of drug or food allergies, especially those who were allergic to any ingredient in this product and its excipients;
• Individuals with a history of hypoglycemia;
• Individuals deemed ineligible by the clinical research physician due to significant clinical abnormalities in medical history, physical examination, laboratory tests, and other related examinations;
• Individuals with a history of smoking addiction within 12 months prior to screening (the number of cigarettes smoked ≥5 per day);
• Individuals with a history of alcohol abuse within the past 12 months (consuming ≥14 units of alcohol weekly: 1 unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine), or who tested positive for alcohol on breath tests prior to study enrollment (testing value \>0mg/100mL);
• Individuals with a history of substance abuse within the past 12 months or who tested positive for addictive substances prior to enrollment;
• Individuals who underwent surgery within the past 3 months, especially those who had had surgeries that would affect drug absorption, distribution, metabolism, or excretion, or those planning to undergo surgery during the study;
• Individuals who had taken any medication that interacts with the trial drug in the 30 days prior to screening, such as strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, etc.);
• Individuals with a history of cardiovascular, liver, kidney, pulmonary, gastrointestinal, neurological diseases, especially any surgical conditions or disorders that might affect drug absorption, distribution, metabolism, and excretion, or any surgical conditions or disorders that might pose hazards to participants;
• Individuals with febrile illness within the 3 days prior to screening;
• Individuals who had participated in any other clinical trials within the past 3 months;
• Individuals with any history of prescription drugs, over-the-counter drugs, herbal medicine, or dietary supplements within 14 days prior to screening;
• Individuals who had consumed excessive tea, coffee, and/or caffeinated, xanthine, or alcoholic beverages (more than 8 cups, 1 cup = 250 mL) daily within the 3 months prior to screening;
• Individuals who had lost blood or donated ≥200 mL within the past 8 weeks;
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• Henan Genuine Biotech Co., Ltd.: lead

Study Sites (1)

Tianjin People's Hospital

Tianjin, China

Location

MeSH Terms

Interventions

dolutegravir

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: May 13, 2025
• First Posted: June 3, 2025
• Study Start: December 9, 2021
• Primary Completion: February 23, 2022
• Study Completion: September 9, 2022
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CN (1)