problems with sexual functioning Sexual dysfunction
Conditions
Interventions
None listed
Sponsors
EB FlevoResearch BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Females between 18 and 55 years of age (both inclusive) 3. Healthy based on medical history, physical examination, electrocardiogram, laboratory values and vital signs 4. Body mass index (BMI) >=18 kg/m2 and
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg 2. Systolic blood pressure 40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms) 8. Use of any drugs from two weeks prior to admission to the research unit until the follow-up visit, except for allowed oral contraceptives and pain relief (e.g. paracetamol up to 1.5 g per day) 9. Known or suspected hypersensitivity to any of the components of the formulation 10. Liver function tests (i.e., ALT, AST and bilirubin) significantly above the upper limit of normal at repeated measures 11. Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator 12. Smoking 13. Unwilling or unable to refrain from consuming grapefruit juice, star fruit, and St. Johns Wort 24 hours before and after intake of medication 14. Current regular use of any illicit drugs or history of excessive drinking within 3 months prior to admission to the research unit and/or unwilling or unable to refrain from products containing alcohol from 24 hours before admission and during the stay in the research unit 15. Donation of blood within 3 months prior to admission to the research unit 16. Positive serology test for HBsAg, anti HAV (IgM), anti HCV or anti HIV 1+2 17. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason 18. Participation in any clinical study within 1 month prior to the expected date of enrolment into the study. 19. Employees of the sponsor or CRO involved in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic 90% CI ratio for both AUC0-inf and Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Difference in Tmax and tlag and - Area under the concentration time curve (AUC) - Peak exposure (Cmax) - Time to peak exposure (Tmax) - Lag time (tlag) - Terminal elimination half-life (t*) Safety A. Nature, frequency and severity of AEs B. Vital signs and 12-lead ECG C. Safety laboratory tests (urinalysis, haematology, biochemistry) | — |
Countries
Netherlands
Outcome results
None listed