None listed
Conditions
Interventions
Intervention1: Colloidal Nano Silver Gel (SilverSol ): Internal Application: The dose is 4 gm of gel, once daily at bedtime, inserted into the vagina using an applicator device for a period of 14 days
Sponsors
Viridis BioPharma Pvt Ltd
Biosphere Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy Adult female subjects between 18 to 40 years of age (Both Inclusive). - Body Mass Index (BMI) between 18.50 30.00 Kg/m2. - Healthy female subjects as evaluated by personal history, medical history, medical examination, and gynaecological examination at screening visit. - Subjects with normal menstrual history with regular cycles with a minimum of 21 days between menses. - Volunteer with Laboratory evaluations within normal range or clinically non-significant at screening visit. - Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen and Hepatitis C antibody. - Non-smoker. - Normal PAP smear result. - Volunteer who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. - Volunteer who can provide adequate evidence of their identity. - Volunteer who are willing to abstain from sexual intercourse or use a reliable method of contraception during the study. - Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test performed within 21 days prior to initiation of the study.
Exclusion criteria
Exclusion criteria: - History of or known sensitivity/allergy to any component of study product. - Volunteer Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3 months. - Volunteer with Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening. - Presence of any clinically significant genital epithelial findings such as abrasions, ulcerations, lacerations at screening. - Have an abnormal PAP test performed at the time of screening. - Presence of any other clinically significant abnormal physical finding on the vulva, vaginal walls or cervix at screening. - Volunteer with any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major diagnosed disease or malignancy. - History of hysterectomy or menopause. - History of gynaecological surgery or procedure within past 2 months. - Received systemic or intravaginal antifungal, antibacterial or anti-parasitic drugs within 14 days prior to the first application of study medication. - History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months, including break-through bleeding requiring sanitary protection. - Known history of HIV, HCV and HBsAg. - Known current alcohol abuse and Consumption of alcohol within 48.00 hours prior to check in or difficulty in abstaining from alcohol for the duration of the study. - History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the in-house stay and history of consumption of caffeine and /or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for at least 24.00 hours prior to check-in. - History of Consumption of tobacco and tobacco containing products, grapefruit and its juices for at least 48.00 hours prior to check in. - Intake of OTC products, herbal medications, etc. within 7 days prior to check-in. - Intake of any prescription medications within 14 days prior to check-in that could affect the kinetics or dynamics of study medications in view of investigator. - An unusual diet for whatever reason (e.g. low sodium diet) for three weeks prior to check-in. - Donation or significant loss of whole blood (480 mL or more) within 30 days or serum within 14 days prior to screening. - Participation in any other clinical research trial involving investigational or marketed products currently or within 90 days of participation prior to screening. - Any other condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives. - Unable to comply with study requirements, including but not limited to, attending all study visits, using the gel as directed, observing abstinence throughout the study and use of effective contraceptives. - Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to check in. - Personal or family history of muscular disorders. - Volunteer having any deformity that will affect venous access for cannulation. - eGFR less than 60 ml/min. - Female who is pregnan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of safety and tolerability will be based on the frequency of adverse events and local tolerance.Timepoint: 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation of Colloidal Nano Silver.Timepoint: Day 1: - At 00.00 hours within 01.00 hour prior to intra vaginal application. - At 02.00, 04.00, 06.00, 08.00, 12.00 & 24.00 hours Post intra vaginal application. Day 14: - At 00.00 hours within 01.00 hour prior to intra vaginal application. - At 02.00, 04.00, 06.00, 08.00, 12.00 & 24.00 hours Post intra vaginal application. | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed