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Healthy Volunteers clinical trials

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NCT ID: NCT01356550 Completed - Healthy Volunteer Clinical Trials

A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.

NCT ID: NCT01355588 Completed - Healthy Volunteers Clinical Trials

Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers

Start date: August 2005
Phase: Phase 1
Study type: Interventional

This was a phase 1, double-blind, 4-way crossover study in healthy male and female volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg. There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine hydrochloride. At the end of the study each subject had received all 4 treatments. The primary objective of this study in healthy volunteers was to compare the safety, tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary objective was to monitor lidocaine hydrochloride plasma levels.

NCT ID: NCT01355354 Completed - Healthy Volunteers Clinical Trials

Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the drug interaction between fostamatinib and digoxin by comparing the safety, tolerability and plasma concentration of digoxin when administered alone and with fostamatinib in healthy subjects.

NCT ID: NCT01354496 Completed - Healthy Volunteers Clinical Trials

A Study of LY2409021 Formulations and the Effect of Food

Start date: April 2011
Phase: Phase 1
Study type: Interventional

The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food. The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods. There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.

NCT ID: NCT01352949 Completed - Obesity Clinical Trials

Stereophotogrammetry of the Torso in Healthy Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity

Start date: June 2, 2011
Phase:
Study type: Observational

Background: - Stereophotogrammetry (SP) uses four sets of digital cameras to generate a three-dimensional computer image. Unlike other types of evaluations which require radiation, SP only uses computer images to learn more about physical deformities such as scoliosis or about the placement of fat on the body. To refine the SP process, researchers are interested in collecting images and body data from individuals with skeletal structural problems such as scoliosis or chest wall deformities, individuals who are overweight or obese, and healthy volunteers. Objectives: - To use stereophotogrammetry to study different individual body types and refine existing imaging techniques. Eligibility: - Individuals at least 2 years of age who have spine, rib, or chest wall deformities; are overweight or obese (body mass index greater than 25); or are healthy volunteers. Design: - Participants will be screened with a physical examination and medical history. The physical examination will include measurements of range of motion and joint mobility, torso width and length, and other observational data. - Healthy volunteers and participants in the obesity group will also have bioelectric spectroscopy (bioimpedance), which uses an additional machine to measure how fat is spread in different parts of the body. - After the physical examination has been completed, participants will have SP photographs taken. Participants will be asked to remove all clothing from the torso, stand with arms raised at the center of four cameras, and remain still while several images are taken. A complete image takes less than 1 second. - Participants with spine or rib deformities, or who are in the obesity group, may also volunteer to return for followup SP imaging, once a year for 5 years, to study progress over time.

NCT ID: NCT01349140 Completed - Healthy Volunteers Clinical Trials

EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks

Start date: February 2012
Phase: Phase 1
Study type: Interventional

EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.

NCT ID: NCT01348737 Completed - Healthy Volunteers Clinical Trials

Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential

NCT ID: NCT01348724 Completed - Healthy Volunteers Clinical Trials

Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118

Start date: June 2011
Phase: Phase 1
Study type: Interventional

Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration.

NCT ID: NCT01346800 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Interaction Between Ritonavir and Prasugrel in Healthy Volunteers

Start date: February 2011
Phase: Phase 1
Study type: Interventional

HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit multiple known risk factors for CVD. Of specific concern is the fact that use of the non nucleosidic reverse transcriptase inhibitors (NNRTI) and/or protease inhibitors (PI) drug classes is associated with dyslipidemia known to increase the risk of coronary heart disease particularly among older subjects with normalized CD4 cell counts and suppressed HIV replication. HIV patients could thus potentially receive anti-aggregant therapy concomitantly with their antiretroviral treatment. Prasugrel is an anti-aggregating agent indicated to prevent the recurrence of ischemic events after coronary arteries stenting. It is a pro-drug mainly metabolized by cytochromes P450 (CYP) 3A and 2B6 and to a lesser extent by CYP2C9 and 2C19. Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in anti-HIV therapy. The aim of the present study is to assess the potential drug-drug interaction between prasugrel and the CYP3A/2B6 inhibitor ritonavir. Ten healthy volunteers will receive prasugrel 10mg alone or after 100mg ritonavir. The effect of ritonavir on prasugrel pharmacokinetics will be assessed. The two sessions will be separated by a one-week "wash out" period. During each session, CYP3A, 2B6, 2C9 and 2C19 activities will be assessed by a micrococktail approach with microdoses of midazolam, bupropion, flurbiprofen and omeprazole. The pharmacokinetics of prasugrel active metabolite will be assessed during the two sessions.

NCT ID: NCT01346670 Completed - Healthy Volunteer Clinical Trials

Lovastatin and Its ß-hydroxy Acid From Four 600 mg LipoCol Forte® Capsules Compared to That of One 20 mg Mevacor® Tablet in Healthy Subjects

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The objective of the study is to evaluate the relative bioavailability of lovastatin and its ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor® Tablet after single oral administration in healthy subjects using a 2x2 crossover design.