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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…

The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)

In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.

Ribavirin: its dosing regime

Is the area under the curve (AUC) of the dose ribavirin once daily equal to the AUC of a half dose twice daily?

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…

A Study to Evaluate the Comparative Bioavailability of Formulation Batches of MK-3682A
Fixed-Dose Combination Tablet (MK-3682/MK-5172/MK-8742, 225 mg/50 mg/25 mg) in
Healthy Adult Subjects

Primary ObjectiveTo evaluate and compare the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites MK-5172, and MK-8742 following administration of three test premarket…

Bioequivalence study of crushed Triumeq with or without drip feed compared to the whole tablet.

Primary objectives:To assess the bioequivalence of a single-dose TRI as a whole tablet (reference) compared to a crushed and suspended tablet (intervention I).To assess the bioequivalence of a single-dose TRI as a whole tablet (reference) compared…

Relative bioavailability study to investigate a potential interaction between dolutegravir (DTG) and tenofovir alafenamide fumarate/emtricitabine (F/TAF) administered as paediatric tablet formulations.

Primary objectives:- To assess the relative bioavailability of TAF and TFV after a single-dose FTC/TAF 3x60/7.5 mg DT (reference TAF) compared to TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as…

Study A: A placebo-controlled crossover study to assess safety of intranasal administration of palivizumab
Study B: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection - a double-blind randomized controlled trial

Study A: Safety of intranasal administration of palivizumab in healthy adultsStudy B: Effect of local administration of palivizumab on prevention of RSV infection

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…

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of
Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55
Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and…

Biocomparison study of crushed elbasvir/grazoprevir compared to the whole tablet (CRUSADE-2)/Hep-NED005

Primary objective:To assess pharmacokinetic similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a whole (reference) tablet.Secondary objective:To assess Cmax similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a…

Bioequivalence study of CRUshed Sofosbuvir/velpAtasvir compareD to the wholE tablet (CRUSADE-1)/Hep-NED004

Primary objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…

Influence of the acidic beverage cola on the absorption of the HCV agent velpatasvir in healthy volunteers being treated with the proton pump inhibitor omeprazole.

Primary objective:To assess the bioequivalence of single-dose velpatasvir administered as a fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) when given with cola + omeprazole 40mg (test 1/trt A) compared to velpatasvir…