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Palatability testing of a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children - VALID 0

PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…

An Open-Label, Single Dose, 4-Period, 4-Way Randomized Crossover Study to Evaluate the Pharmacokinetics of Preliminary Market Formulations of MK-8408 in Healthy Adult Subjects.

Primary:1. To assess the pharmacokinetic profiles following single dose administration of MK-8408 administered as a PMF1 tablet by means of AUC0-*, AUClast, AUC0-24, Cmax, C24, tmax, and t* under fed conditions, following a high fat meal. 2. To…

An Open-Label Two-Way Drug-Drug Interaction Study to Assess the Effect of Tenofovir on the Pharmacokinetics of BMS-790052 and the Effect of BMS-790052 on the Pharmacokinetics of Tenofovir in Healthy Subjects

The purpose of the study is to investigate the effect of multiple oral doses of Tenofovir on how quickly and to what extent BMS-790052 is absorbed and eliminated from the body and the effect of multiple oral doses of BMS-790052 on how quickly and to…

A Phase I randomized, open-label, single dose, 3-period crossover trial in healthy subjects to evaluate the relative oral bioavailability of the 25 mg and 100 mg tablets of TMC125.

The objective of this study is to evaluate the concentrations in blood after a single administration of 100 mg TMC125. The various administration formulations will be compared to demonstrate that the formulations can be exchanged. The administration…

A phase I, open-label, randomized crossover trial in 24 healthy subjects to investigate the effect of steady-state esomeprazole on the pharmacokinetics of a single dose of telaprevir.

This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…

A Phase I randomized, open-label, single dose, 4-period crossover study in healthy subjects to evaluate the relative oral bioavailability of two tablet strengths of TMC125 and the effect of coating on bioavailability.

The objective of this study is to compare the bioavailability of 100 and 200 mg pills that are produced in different ways: coated or non-coated. Bioavailability means the amount of medication which is available for use in the body. In this study the…

A Phase I, open-label, randomized, 2-way crossover trial in 40 healthy subjects to investigate the potential pharmacokinetic interactions between telaprevir and darunavir/ritonavir and between telaprevir and fosamprenavir/ritonavir at steady-state

The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. The secondary objective is to…

A Phase I, open-label, randomized, 2-way crossover trial in 2 parallel panels of 20 healthy subjects each to investigate the pharmacokinetic interaction between lopinavir/ritonavir (LPV/rtv) and telaprevir, and between atazanavir/ritonavir (ATV/rtv) and telaprevir, all at steady-state.

The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…

A drug-drug interaction study between the novel anti-HCV agent DAclatasvir and The antidiabetic agent mEtformine in healthy volunteers.

Primary objective:•To assess the effect of multiple dose daclatasvir (60mg QD) on the pharmacokinetics (AUC, Cmax, Ctrough, CLr) of multiple dose metformin (1,000mg BID) by intra-subject comparison, in healthy subjects.Secondary objective:•To assess…

A drug-drug interaction study between the novel anti-HCV agent daclatasvir and the antiretroviral agents atazanavir/ritonavir or atazanavir/cobicistat in healthy volunteers.

Primary objective:To compare the effect of multiple dose atazanavir/cobicistat on the multiple dose phar-macokinetics of daclatasvir with the effect of atazanavir/ritonavir on the multiple dose of daclatasvir by intra-subject comparison in healthy…

A study to evaluate the relative bioavailability and effect of food on two 450mg MK-3682 Fixed-Dose Combination Formulations (MK-3682 /MK-5172 /MK-8408)

- To evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations…

A study to evaluate the relative bioavailability and effect of food on MK-3682B Fixed-Dose Combination Tablet (MK-3682/MK-8408/MK-5172)

- to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixeddose combination…

Markers of Oxidative Stress from Supplemental Oxygen in critically-ill children

This study has two parts. The main objective of part 1 (in vivo) is todetermine changes in markers of oxidative stress in exhaled breath as a result of different short term oxygenation strategies (liberal versus conservative) . The main objective of…