Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.
Double-blind, randomized, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BP101 after multiple doses administration in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Research center Eco-Safety LLC
Saint Petersburg, Russia
Incidence of treatment-emergent Adverse Events
To evaluate frequency, seriousness, and severity of adverse events, including events of dose-limiting toxicity in healthy volunteers receiving different doses of BP101 compared to placebo after multiple administrations.
Time frame: 6 weeks
BP101 maximum plasma concentration (Cmax)
To determine pharmacokinetic parameter of maximum plasma concentration (Cmax) after single administration of BP101 in healthy volunteers.
Time frame: Day 1
BP101 area under the concentration versus time curve (AUC)
To determine pharmacokinetic parameter area under the plasma concentration versus time curve (AUC) after single administration of BP101 in healthy volunteers.
Time frame: Day 1
BP101 time to maximum plasma concentration (Tmax)
To determine pharmacokinetic parameter time to maximum plasma concentration (Tmax) after single administration of BP101 in healthy volunteers.
Time frame: Day 1
BP101 half-life time (T1/2)
To determine pharmacokinetic parameter of plasma half-life time (T1/2) after single administration of BP101 in healthy volunteers.
Time frame: Day 1
Change from Baseline in Female Sexual Function Index score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Time frame: 2 weeks
Change from Baseline in Female Sexual Function Index score
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To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function Index (FSFI).
Time frame: 6 weeks
Change from Baseline in Female Sexual Distress Scale-Revised score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Time frame: 2 weeks
Change from Baseline in Female Sexual Distress Scale-Revised score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Distress Scale-Revised (FSDS-R).
Time frame: 6 weeks
Change from Baseline in Female Sexual Function questionnaire score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Time frame: 2 weeks
Change from Baseline in Female Sexual Function questionnaire score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Female Sexual Function (FSF) questionnaire.
Time frame: 6 weeks
Change from Baseline in Arizona Sexual Experience Scale score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Time frame: 2 weeks
Change from Baseline in Arizona Sexual Experience Scale score
To evaluate impact of BP101 in comparison with placebo on sexual function in healthy volunteers using Arizona Sexual Experience Scale (ASEX) questionnaire.
Time frame: 6 weeks