Status:
COMPLETED
Safety and Tolerability Studies of CanProFem-AK, Vaginal Suppositories in Healthy Volunteers
Lead Sponsor:
Industrial Microbiology LLP
Conditions:
Candidosis Vaginal
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
The study object of this clinical trial is CanProFem-AK, 100 mg suppositories. The Pharmacological group - Antifungal drug for external use. The active drug substance is the antifungal antibiotic Rose...
Detailed Description
The study object of this clinical trial is CanProFem-AK, 100 mg suppositories. The Pharmacological group - Antifungal drug for external use. Fungal infections are one of the most demanding and unreso...
Eligibility Criteria
Inclusion
- Healthy female volunteers aged 18-40 years with verified health status and no chronic or acute systemic or dermatological diseases.
- Willingness to voluntarily participate in the study.
Exclusion
- Individuals with chronic diseases (tuberculosis, hepatitis, HIV infection, diabetes mellitus, cancer), chronic renal failure, chronic liver failure, exacerbations of chronic diseases;
- Individuals participating in parallel clinical trials of other drugs, or who participated within 3 months from the start of the current study;
- Individuals from the category of "vulnerable patients" (homeless, military personnel, incapacitated persons, patients in emergency situations, and other individuals who may be the subject of pressure);
- Patients with an allergy in their medical history and during screening (medicinal, pollen and other types);
- Patients with a history of oncopathology or a family history of oncopathology (the presence of oncopathology among close relatives);
- Patients with hypersensitivity to one of the components of the study drug;
- Pregnancy and breastfeeding;
- Patient's refusal to perform the procedures required by the protocol and inability to adhere to the procedure schedule.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06535126
Start Date
June 1 2024
End Date
June 2 2024
Last Update
August 2 2024
Active Locations (1)
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1
MIPO Clinic LLP
Almaty, Kazakhstan