12 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
The primary goal of this study is to investigate the effect of low doses of mirtazapine and quetiapine on sleep, assessed using polysomnography and subjective sleep measures, of healthy subjects whose sleep will be disturbed by auditory stimuli (…
The objective of this study is to investigate whether subjects who have taken esketamine, will be able to drive a car as soon as their cognitive function has been restored. The residual effects on driving performance will be compared to placebo.…
Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…
To study the effect of high dose oral cholecalciferol suppletion on serum 25-OHD in elderly with osteoarthritis of the hip.
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
A pilot study the effect of high dose oral cholecalciferol suppletion on serum 25-OHD in elderly with osteoarthritis of the hip.
This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…
The objective of the current study is to investigate the possible effects on driving ability of a new anti-depressant (10 mg Lu AA21004) after 1 day of dosing and after 15 days of dosing. These effects will be compared to those of mirtazapine (30 mg…
This study is a Phase II, non-randomized, open label trial to evaluate Safety and Antiviral activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.
To suppress low-level viremia to a level below 50cp/mL in patients using cART by switching their current non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI to DRV boosted with ritonavir (RTV) (DRV/r). Secondary objectives are to reduce the…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…