Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers (NCT03102489) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers
Russia18 participantsStarted 2017-02-22
Plain-language summary
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy women aged from 18 to 40, inclusive.
* Verified diagnosis "healthy": absence gastrointestinal, hepatic, renal, cardiovascular, endocrine, central nervous system, ear, nose, throat (ENT) and gynecological disorders (performed standard clinical, laboratory and instrumental assessments did not reveal any disorders).
* Body mass index (BMI) within range from 18.5 to 30 kg/m\^2.
* Subject consent not to intake alcohol during the entire study period; negative alcohol breath test at screening and before start of Investigational Product administration.
* Negative pregnancy test result at screening and before start of Investigational Product administration.
* Consent to use adequate methods of contraception throughout the study.
* Normal regular menstrual cycle of 28 +/- 7 days duration for at least 6 months before study enrollment.
* Women with stable sexual partner.
Exclusion Criteria:
* Chronic cardiovascular, respiratory, neuroendocrine, genitourinary systems disorders, as well as gastrointestinal, hepatic, renal, blood, and ENT disorders (including acute and chronic rhinitis, sinusitis, and others).
* Gynecological disorders (polycystic ovary syndrome, mommas, endometriosis, inflammatory diseases and others).
* Positive cervical cytology Papanicolaou (PAP) test in medical anamnesis within 12 months before screening.
* Lab abnormalities (blood hematology and biochemistry and urinalysis) at screening.
* Electrocardiogram (ECG) abnormalities at scree…