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Healthy Participants clinical trials

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NCT ID: NCT01448824 Completed - Clinical trials for Healthy Participants

A Study of LY2484595 on Pharmacokinetics in Healthy Participants

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

This is a 2-part study. Part 1 is to determine the safety and tolerability in healthy participants of increasing daily doses of LY2484595 for 14 days to achieve a blood level of LY2484595 much higher than what is needed for therapy. The amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it will be determined. The effect of the study drug on factors in the blood related to cholesterol will be measured. Part 2 is to determine how ketoconazole affects how much of the study drug, LY2484595, gets into the bloodstream and how long it takes to get rid of it. Information about any side effects that may occur will also be collected.

NCT ID: NCT01372085 Completed - Clinical trials for Healthy Participants

Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702

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

This is a single-centre, placebo-controlled, two-part study in healthy participants. Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.

NCT ID: NCT01325324 Enrolling by invitation - Clinical trials for Healthy Participants

Comparison of Different Portable Tonometers (Icare Pro, TONO-Pen AVIA, Perkins Tonometer, PASCAL Hand Held Dynamic Contour Tonometer)

Start date: March 2011
Phase: Phase 4
Study type: Interventional

In different cases intraocular pressure (IOP) have to measured in lying position. Therefore a lot of portable tonometers have been established. The Icare Pro is a new tonometer on the market that allows faster and more comfortable IOP-measurements. No local anesthesia is needed, what is a major advantage for the patients. In this study the investigators want to evaluate if IOP measurements with Icare Pro Tonometer are as reliable as they are with other established portable tonometers (Perkins, TONO-Pen and hand held-Dynamic Contour Tonometer). - Trial with medical device

NCT ID: NCT01252368 Completed - Hypertension Clinical Trials

Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)

Start date: December 2009
Phase: N/A
Study type: Observational

Aim of this trial is to investigate the expression and localisation of different amino acid transporters and their regulatory proteins derived from the regulatory proteins of the local renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients who do not take any drugs interfering with RAS. On the other hand expression analysis is done in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes. After obtaining informed consent of patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum and descending colon. Biopsies are investigated anonymously at the Institute of Physiology of the University of Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed with immunohistochemistry. Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are measured.

NCT ID: NCT01220167 Completed - Clinical trials for Healthy Participants

Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

Start date: August 2008
Phase: Phase 1
Study type: Interventional

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

NCT ID: NCT01051466 Completed - Clinical trials for Major Depressive Disorder

A Study of the Neurobiology of Depression

Start date: January 2010
Phase: Phase 4
Study type: Interventional

Previous research studies have shown that depression is associated with changes in structure and activity in different parts of the brain and that antidepressant medication can affect brain activity in different parts of the brain in individuals suffering from depression. The primary purpose of the study is to find out more about how the antidepressant medication duloxetine affects brain activity and structure in individuals with depression.

NCT ID: NCT00946816 Completed - Obesity Clinical Trials

The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity

Start date: September 2010
Phase: N/A
Study type: Interventional

Diseases characterized by abnormal low and high body weight are common in the community and are associated with significant morbidity, mortality and health care related costs. Genetic, dietary, social and psychologic factors all play an important part in these conditions; however the central role of gastrointestinal (GI) function and the control of nutrient delivery to the small bowel has not been well described in health or disease. We propose that the GI response to feeding varies inversely with body weight. This hypothesis predicts that as body weight increases, the response to a given meal decreases in terms of motility, neurohormonal feedback, sensation and satiety. This provides an attractive explanation for why thin individuals stop eating after a small amount of food (i.e. limited gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early satiety)and, conversely, why obese patients continue to eat even after nutritional requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak nutrient feedback with delayed satiety). This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback, visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and high (morbid obesity) body weight and in healthy, normal weight controls. Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9 kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1: anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2 years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years) and C2: obese with DM type II (n=20 over 2 years). Two studies will be performed 1. Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback, visceral sensation and satiety in healthy controls and in patients with anorexia and obesity 2. Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI motility, hormonal feedback, visceral sensation and satiety in patients with anorexia and obesity

NCT ID: NCT00943696 Completed - Clinical trials for Healthy Participants

Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers

Start date: August 2009
Phase: Phase 4
Study type: Interventional

Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract. In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design. The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.

NCT ID: NCT00933283 Completed - Clinical trials for Healthy Participants

A Study to Investigate the Potential Interaction Between Telaprevir and Methadone, at Steady-State

Start date: July 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.

NCT ID: NCT00867867 Completed - Clinical trials for Healthy Participants

Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries

Start date: October 2003
Phase: Phase 1
Study type: Interventional

Iron fortification of foods is usually considered the most cost-effective approach to prevent iron deficiency. However, iron is the most difficult mineral to add to foods. When added as water-soluble, highly bioavailable compounds such as ferrous sulfate, the soluble iron rapidly catalyzes fat oxidation resulting in rancid products. In addition, water-soluble iron compounds can cause unacceptable color reactions during storage and food preparation. Thus, food manufacturers are often obliged to use water-insoluble iron compounds to fortify foods and fortification compounds such as elemental Fe powder and ferric pyrophosphate are widely used to fortify cereal flours and infant cereals. However, these compounds never dissolve completely in the gastric juice and are usually far less well absorbed than ferrous sulfate (Hurrell 1997). Ferrous fumarate on the other hand, although almost insoluble in water, readily dissolves in the gastric juice and has been shown to have an equivalent absorption to ferrous sulfate in healthy, Western adults (Hurrell et al. 1989, 2000). Because it is non-water soluble, it causes relatively few sensory problems in the fortified foods and is therefore an interesting food fortificant. Iron absorption from ferrous fumarate has been demonstrated to be significantly higher than from ferric pyrophosphate in European infants (Davidsson et al. 2000) and this compound is currently used to fortify blended cereal flours for food aid programs and commercial infant cereals in Europe. However, based on our recent study in Bangladeshi children, there is now concern that due to lower gastric acid output, young children in developing countries may not be able to absorb ferrous fumarate as well as Western adults (Davidsson et al. 2001a, Sarker et al. 2001, 2003). Clearly, there is a need to evaluate the efficacy of water insoluble iron compounds to prevent the development of iron deficiency/iron deficiency anemia in infants and young children living in developing countries. The aim of this study is to evaluate the efficacy of ferrous fumarate and ferric pyrophosphate, as compared to ferrous sulfate, as food fortificants in preventing development of anemia/IDA in Bangladeshi infants and young children (part I). A potential cause of low gastric acid secretion in Bangladesh and many developing countries is Helicobacter pylori infection. Although H. pylori-infection appeared to have no influence on absorption of ferrous fumarate in children, the impact of chronic H. pylori infection in adults could be expected to be more pronounced due to long time effects on the gastric mucosa, resulting in reduced gastric acid output. The other aim of the study is therefore, to assess of iron absorption and gastric acid output in adult women of child-bearing age with H. pylori infection (part II). Two hundred and forty non-anemic Children (Hb>105 g/L) will be randomized to three study groups; ferrous fumarate, ferric pyrophosphate or ferrous sulfate (n=80 per group) in wheat flour- and cow milk-based infant formula and will be fed for 9 months. Hemoglobin, serum ferritin, and transferin receptor will be analyzed at baseline and after 4.5 and 9 months of intervention. Prevalence of anemia and iron deficiency during and after the intervention among the three groups will be compared (part I). We furthermore propose a complementary study to determine the relative absorption of ferrous fumarate (relative to ferrous sulfate) in H. pylori infected and non-infected adult Bangladeshi women (15 each) of 20-40 year of age with IDA using stable isotope technique based on the incorporation of iron stable isotopes into erythrocytes 14 days after administration. Assessment of gastric acid output will also be performed. Iron stature and absorption, and assessment of gastric acid output will be compared before and after therapy in H. pylori infected women (part II). The results of this study are expected to have implications in the prevention and treatment of iron deficiency anemia in developing countries