Safety and Tolerability Studies of CanProFem-AK, Vaginal Suppositories in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

June 2, 2024

Study Completion Date

June 2, 2024

Conditions
Candidosis Vaginal
Interventions
DRUG

CanProFem-AK

Dosage form - vaginal suppositories (100 mg). Dosage regimen - single intravaginal administration of suppository. Vaginal suppositories are inserted as deeply as possible while the participant is lying down; the participant must remain in a horizontal position for 45 minutes after the administration. The total duration of volunteer participation in the study is one day. Medical observation (including gynaecological monitoring with vaginal bacterial swab test) of the subject condition after the drug administration will be carried out after 3, 6, 9, 12 and 24 hours. Repeated laboratory blood and urine tests will be performed after 24 hours. Participants of the study will be closely monitored for 24 hours after the initial administration of the drug to detect any immediate adverse events. If the subject experiences an immediate adverse event, appropriate treatment will be provided.

Trial Locations (1)

Unknown

MIPO Clinic LLP, Almaty

All Listed Sponsors
lead

Industrial Microbiology LLP

OTHER

NCT06535126 - Safety and Tolerability Studies of CanProFem-AK, Vaginal Suppositories in Healthy Volunteers | Biotech Hunter | Biotech Hunter