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NCT ID: NCT03658720 Terminated - Healthy Clinical Trials

Nurofen Ibuprofen Orodispersible Tablet Disintegration Study

Start date: December 19, 2017
Phase: N/A
Study type: Interventional

Disintegration time is an important quality attribute of ODTs, and the evaluation of disintegration time is positioned as a key step in formulation development, manufacturing, and clinical practice. The standard recommended over-the counter dose of 200mg Nurofen ibuprofen ODT is one (200mg) to two (400mg) tablets. To reflect this, the disintegration time of both one (200mg) and two (400mg) tablets will be assessed in this study. Studies have been performed assessing in vivo ODT disintegration time and have created standardised oral conditions by giving water prior to dosing, to moisten/wet the mouth. In this study it is therefore necessary to standardise the oral conditions as much as possible, despite the interpersonal variability, to measure the time it takes for the ODT to disintegrate. For this study, 20 mL of water is swallowed prior to dosing to standardise oral conditions. Thirty-three healthy volunteers are required to be randomised into the study, to allow evaluable data to be obtained for 30 subjects. Subjects are given a light meal/snack and then fast for 2 hours 15 minutes (± 15 minutes) before dosing, in order to bring the oral cavity environment as close as possible to standard levels and to minimise variability in salivation. Directly before dosing, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects are dosed according to the sequence they have been randomised and the ODT disintegration time assessed. Following the first dose, subjects complete a washout period of a minimum of 4 hours, in accordance with the recommended posology, before receiving the second dose. During this washout period, subjects are given a second light meal/snack (the same as the previous light meal/snack), timed to allow subjects to fast for 2 hours 15 minutes (± 15 minutes) before the second dose. Directly before the second dose, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects then receive the alternative dose to the dose they received during the first assessment, in accordance with the randomisation sequence. Following completion of the disintegration assessments, or upon subject withdrawal, subjects are asked whether they are experiencing any symptoms or complaints. Any AEs are recorded in the CRF and followed up as necessary by the Investigator. Subjects then leave the clinic.Subjects are contacted by the Investigator (or designee) from 24 to up to 48 hours to ensure any AEs are captured.

NCT ID: NCT03468777 Terminated - Healthy Clinical Trials

A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants

Start date: March 6, 2018
Phase: Phase 1
Study type: Interventional

The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.

NCT ID: NCT03468543 Terminated - Healthy Clinical Trials

Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects

Start date: July 26, 2017
Phase: Early Phase 1
Study type: Interventional

To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

NCT ID: NCT03411421 Terminated - Healthy Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers

Start date: March 3, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system [CNS] related events such as lightheadedness and dizziness), of multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.

NCT ID: NCT03297008 Terminated - Healthy Clinical Trials

Biomarkers in Saliva and Stool

Start date: March 11, 2015
Phase: N/A
Study type: Observational

To collect saliva and stool samples using the salimetrics swab and self-stool collection kit, process and store samples in a standardized manner. Following this, perform immunological assays such as enzyme-linked immunosorbent assay, multiplex bead assay and Immunocap to correlate the salivary and fecal levels of biomarkers in healthy donors. As this method is non-invasive, we believe that more people will be willing to donate samples.

NCT ID: NCT03180762 Terminated - Healthy Clinical Trials

A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Participants

Start date: May 30, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose administration.

NCT ID: NCT03139500 Terminated - Healthy Clinical Trials

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants

Start date: May 17, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).

NCT ID: NCT03126097 Terminated - Healthy Clinical Trials

A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females

Start date: April 13, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the effect of single and multiple doses of JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone and vice versa in healthy female participants.

NCT ID: NCT03116581 Terminated - Healthy Clinical Trials

Altruistic Decisions

Start date: February 3, 2014
Phase: N/A
Study type: Interventional

The study aimed to understand how payoffs for others influence perceptual decision making. The research consists in testing how varying monetary payoffs for another modify the perceptual decision making processes. The use of drift diffusion models on a random dots task enable the characterization of the decision parameter(s) that are modulated when a decision is made to win payoffs for others as compared to decisions for self-benefits. Once the parameter revealed through behavioral experiment, neuroimaging is applied to find the neural correlates of the effects of taking others into account in the decision making process.

NCT ID: NCT03095833 Terminated - Healthy Clinical Trials

Food Intake Decisions

Start date: February 27, 2015
Phase: N/A
Study type: Interventional

Functional Magnetic resonance study on the effect of cognitive context variables on the perception and valuation of food odorants and flavor. The study is composed of two experiments; in a first experiment we address the question of how valuation of food odors are modulated by 3 cognitive conditions (indulgence, healthy, and neutral). Food odors are delivered using a custom-made olfactometer. Here we hypothesize that cognitive regulation can modulate the primary sensory processing of food odors. We expect that cortical regions related with valuation and cognitive regulation such as the ventromedial prefrontal cortex and the dorsolateral prefrontal cortex operate the modulation of primary olfactory cortex and amygdala. In a second experiment, we aim to reveal the brain areas involved in integrating food color cues with odor and taste stimuli. Here we hypothesize that color cues are capable of biasing flavor attributes of food (flavor intensity), and that this bias occurs at different cortical areas commonly associate with multisensory integration such as the orbitofrontal cortex, insula, amygdala and hippocampus.