ybridos Food effect studyVoedsel effect onderzoek naar Lybridos
- Conditions
- Seksueel functioneren, Seksuele disfunctie
- Registration Number
- NL-OMON22366
- Lead Sponsor
- EB FSD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Provision of informed consent
2. Females between 18 and 55 years of age (both inclusive)
Exclusion Criteria
Cardiovascular conditions
1. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90% CI ratio for both AUC0-inf and Cmax
- Secondary Outcome Measures
Name Time Method Pharmacokinetic<br /><br>Difference in Tmax and tlag and<br /><br>-Area under the concentration time curve (AUC)<br /><br>-Peak exposure (Cmax)<br /><br>-Time to peak exposure (Tmax)<br /><br>-Lag time (tlag)<br /><br>-Terminal elimination half-life (t½)<br><br /><br /><br>Safety<br /><br>A. Nature, frequency and severity of AEs<br /><br>B. Vital signs and 12-lead ECG<br /><br>C. Safety laboratory tests (urinalysis, haematology, biochemistry)