A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

Exclusion Criteria

• •1. Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;
• •2. Presence of concomitant vulvovaginitis caused by other pathogens;
• •3. History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;
• •4. Moderate to severe hepatic and/or renal disorders;
• •5. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;
• •6. Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;
• •7. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
• •8. Presence of significant laboratory abnormalities at screening;
• •9. QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;
• •10. Have planned surgeries or other medical procedures that may impact compliance with the protocol;
• •11. Known history of hypersensitivity or intolerance to azole antifungal drugs;
• •12. Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;
• •13. History of narcotic or drug abuse or alcoholism within 6 months prior to screening;
• •14. Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;
• •15. Other conditions unsuitable for participation in the study per investigator's judgment.