15 results
To compare the pharmacokinetics of sublingual testosterone cyclodextrin followed by buspirone as an encapsulated tablet with administration of testosterone and buspirone as one tablet designed to release the components in a specific time-frame.
Primary objectives:To establish the lowest effective dose using physiological and subjective measures of sexual arousal.To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three (3) doses (0.…
Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…
The primary objective of this study is to evaluate the long-term safety and tolerability of the TAK-491CLD FDC in comparison to the OLM/HCTZ FDC in hypertensive subjects with moderate renal impairment.
Primary objectives:To confirm the lack of effect of 0.5 mg sublingual testosterone on physiological and subjective measures of sexual arousal in women with HSDD. Secondary objective:To confirm the lack of effect of 0.5 mg sublingual testosterone on…
The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be…
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with propofol and daily sedation stops, in maintaining a target depth of sedation in ventilated…
Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…
Answering the following questions:1. Main question: Is remifentanil a usefull medication for PSA in the emergency department?2. What is the recovery time of the patient when using fentanyl / propofol / remifentanil (time between last gift PSA…
We hypothesize that online adaptation or individualization of the population PKPD model of propofol will decrease the residual error between predicted and measured plasma-concentrations during maintenance of anaesthesia, when the adapted PKPD models…
Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…
Primary objectives:- to assess the safety and tolerability of a single ascending intravenous (IV) infusion doses of the research medication.- to determine the maximum tolerated dose (MTD) of IV infusion doses of the research medication.Secundary…
Primary objective1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual…
This study will investigate the counter impulse hypothesis. According to the counter-impulse hypothesis, avoidance motivation counters aggressive impulses. Consequently, this regulatory impact should be especially effective when people*s aggressive…