ybrido Food effect studyVoedsel effect onderzoek naar Lybrido
Completed
- Conditions
- Sexual dysfunction, problems with sexual functioningSeksuele disfunctie, problemen met het seksueel functioneren
- Registration Number
- NL-OMON25592
- Lead Sponsor
- EB FSD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion Criteria
Cardiovascular conditions
1. History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic 90% CI ratio for both AUCinf and Cmax
- Secondary Outcome Measures
Name Time Method 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 (t½) Residual testosterone per tablet and rupture test analysis after: A. 30 sec sublingual administration B. 60 sec sublingual administration C. 90 sec sublingual administration D. 120 sec sublingual administration Safety E. Nature, frequency and severity of adverse events F. Vital signs and 12-lead ECG G. Safety laboratory tests (urinalysis, hematology, biochemistry)