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Healthy Volunteers clinical trials

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NCT ID: NCT00261001 Completed - Healthy Volunteers Clinical Trials

Safety Study Comparing a Vaccine Transcutaneous Administration to the Intramuscular Route

MANON-05
Start date: October 2005
Phase: Phase 1
Study type: Interventional

The rationale for transcutaneous vaccination is based on the unique ability of cutaneous immune cells, especially Langerhans cells (LCs), to present antigens to the immune system. DCs can be found at high densities in the epidermis and the dermis of human skin, a fraction of which are the epidermal LCs. It is known that strong and efficient immune responses can be induced by targeting vaccines to skin APCs (Glenn 2003, Partidos 2003), e.g. by epicutaneous application of smallpox vaccine on scarified skin. Several obstacles however prevent vaccines from attaining sufficiently high and free concentrations in these target skin DCs. In this clinical trial we aim at testing the safety and immunogenicity of this new transcutaneous route of vaccine administration, first with a licensed, well-known, safe and highly immunogenic vaccine i.e. Tetagrip® vaccine, which is licensed for subcutaneous (s.c.) and intra-muscular routes (i.m), and to compare the induced vaccine-specific immune responses to those induced with the conventional (i.m) injection. We hypothesize that the transcutaneous application of Tetagrip® in the commercially available standard preparation of 0.5 ml should be capable to induce at least similar antibody and CD4 and/or CD8 T cell responses to both the tetanus and the flu vaccinal antigens. This Phase I, open label, randomized study is designed to evaluate and to compare the safety and immunogenicity of a transcutaneous mode of Tetanus / Influenza vaccination to the conventional i.m. route of vaccine administration in two cohorts: The cohort I constituted of healthy volunteers and the cohort II of HIV-infected patients in whom the virus is stably controlled by antiretroviral therapy, ensuring an immune competence and a capacity to respond to vaccines.

NCT ID: NCT00257985 Completed - Healthy Volunteers Clinical Trials

Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2

Start date: April 2005
Phase: N/A
Study type: Interventional

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion.

NCT ID: NCT00256802 Completed - Healthy Volunteers Clinical Trials

The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography

Start date: June 2004
Phase: N/A
Study type: Interventional

To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular response during the GTN-induced headache in healthy volunteers.

NCT ID: NCT00256347 Completed - Healthy Volunteers Clinical Trials

Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine

Start date: March 2005
Phase: N/A
Study type: Interventional

30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. The primary purpose is to investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.

NCT ID: NCT00255320 Completed - Clinical trials for Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound

Experimental Headache Induced by Vasoactive Intestinal Polypeptide

Start date: December 2003
Phase: N/A
Study type: Interventional

We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters.

NCT ID: NCT00251030 Completed - Healthy Volunteers Clinical Trials

A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects

Start date: November 2005
Phase: Phase 4
Study type: Interventional

To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects

NCT ID: NCT00241592 Completed - Healthy Volunteers Clinical Trials

Vaporization as a Smokeless Cannabis Delivery System

Start date: August 2004
Phase: Phase 1
Study type: Interventional

A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.

NCT ID: NCT00226538 Completed - Healthy Volunteers Clinical Trials

Prediction of Drug Interactions With CYP2C9 Substrates

Start date: August 1999
Phase: N/A
Study type: Interventional

CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic cytochrome P450 content and being second only to CYP3A4. The proposed study will explore different possible drug interactions with CYP2C9 substrates by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait measurement. It is expected that the identification of drugs that might interact with CYP2C9 substrates will be used to rationalize future drug interaction studies designed to evaluate the actual magnitude of effect and its clinical implications. This approach should be particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic index (i.e. warfarin). This study will consist of three study periods separated from each other by a two weeks washout period. In the course of the study the subjects will receive in a double blind, crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as identical looking tablets that will be prepared at the pharmacy of the Hadassah University Hospital and their order of administration will be randomized.On the day prior to, on day 6 of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin intake.

NCT ID: NCT00223951 Completed - Clinical trials for Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers

NCT ID: NCT00223483 Completed - Healthy Volunteers Clinical Trials

Identification and Analysis of Immunomodulatory Molecules in Patients With Hematologic Disorders and Healthy Volunteers

Start date: March 2005
Phase:
Study type: Observational

This research study goal is to analyze the plasma and the cells that make up part of the immune system. We want to learn how the plasma and cells work. These may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms.