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Drug Discovery Clinical Trials

04:31 EST 23rd January 2019 | BioPortfolio

A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.

SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

The purpose of this phase IIb, national (France), multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 12 months of treatment in SCD adult patients.

ClearSight System CHN Study

The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The results of this study may be used for registration and regulatory submissions.

A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin

This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.

Cannabis Extract in Refractory Epilepsy Study

The purpose of this study is to examine whether a low dose of CBD+THC will decrease the frequency of convulsive seizures in adults with drug-resistant epilepsy, when used in addition to standard anti-epileptic drugs (AEDs). This study will also study the genes associated with epilepsy and whether different epileptic syndromes respond to treatment with CBD+THC.

Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.

Connect-Home Clinical Trial

This study will test whether transitional care targeting care needs of seriously ill, skilled nursing facility (SNF) patients and their caregivers will help to improve SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role. caregiver burden and caregiver distress).

Hypotension Prediction Index Study (HPI Study)

A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)

STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes

Canada is the only country with a universal health insurance system that does not provide coverage for prescription drugs to all residents. One-third of working-age Canadians have no insurance. Importantly, many of these uninsured patients already face other barriers to good health: low income, new immigrants, single mothers, etc. For these patients, taking prescription dru...

Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets

The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®. In order to meet the requirements for registration as a generic drug, this study is being conducted to demonstrate the bioequivalence between the formulation of tramadol hydrochloride/ paracet...

Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment

This study is being done to better understand how genetic information related to drug dosing and use can affect medical care of patients. By doing this study, the investigators are developing and improving ways to incorporate information about drug related genetic variants into the medical record.

A Phase 1, Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.

Phase 1 Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.

Phase 1, Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and simvastatin in healthy male and female subjects.

Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial

This is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.

Clinical Effectiveness Trial of PTM1001 to Reduce Stunting and Ameliorate Environmental Enteric Dysfunction in Malawian Infants

The trial will consist of adding a supplement called PTM1001(4.3 egg powder + 5.7 g bovine colostrum) along with a multiple micronutrient powder to the diet of children 10-13 months of age. This should improve linear growth and gut health. Children will be receive either the supplement or control for 12 weeks. At enrollment at at week 12 stool and urine will be collected. C...

PCD New Gene Discovery

This is a new gene discovery program for individuals with PCD who do not have a specific genetic etiology identified. Research procedures involve a single blood draw from the affected individual and from unaffected family members in an effort to identify new genetic targets.

The Feasibility of Drug Delivery to Infants During Breastfeeding

Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it...

A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma

A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants

The purpose of this study is to assess the effect of steady-state clarithromycin once every 12 hour on the pharmacokinetic parameters of bedaquiline and its active metabolite M2 after a single dose of bedaquiline.

Multi-omics Study of Clinical Endpoints in CHD

This study aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences. It will enroll approximately 4000 coronal heart disease patients aged between 18 and 80 years in mainland China and follow-up for at least 1 years. Questionnaires, anthropometric measures, laboratory tests, ...

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrom...

A First-in-Human Study of Enteral Drug Delivery Device

The objective of this study is to ascertain the efficacy and short-term safety of the RaniPill in healthy volunteers

Rivaroxaban Hypericum Trial

Single-center, open-label, sequential treatment study to investigate the influence of the combined P-glycoprotein and CYP3A4 inducer hypericum perforatum on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy volunteers.

Short-term Effects of Exercise Program Versus Electropuncture in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.

This study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain.

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