There are about 2671 clinical studies being (or have been) conducted in Bulgaria. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved and United States (US)-Licensed Humira. This is a multicenter, randomized blinded, parallel group, interchangeability study in subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and, Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product. The study will also assess safety, efficacy and immunogenicity between these two groups.
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of the 2 active metabolites could be decreased, leading to decreased exposure in hepatic impairment (HI). As there is no experience of use in patients with hepatic impairment, in fexinidazole summary of product characteristics (SmPC) approved by the European Medicines Agency (EMA), fexinidazole is contra-indicated in patients with clinical signs of cirrhosis or jaundice, and in the proposed USA product information, fexinidazole is contra-indicated in patients with liver impairment. Therefore, FDA requested a study with the objective to evaluate the effect of mild and moderate hepatic impairment (HI) on the pharmacokinetics (PK) of fexinidazole and its 2 metabolites, as a post-marketing requirement.
The purpose of this study is to evaluate the efficacy of a probiotic, SINQUANON, on the reduction of the occurrence of diarrhea associated with antibiotic use in adults.
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.
The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.
Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Nebivolol 5 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment inpatients with uncontrolled BP previously treated with Nebivolol (NEB) or Amlodipine (5 mg) monotherapies for at least 4 weeks.
This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly. In people with CKD, the kidneys do not remove wastes and extra fluid from the blood as well as they should. High blood pressure makes it more likely that the CKD gets worse. The study treatment BAY3283142 is under development for treating CKD. It activates a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. As many people with CKD do also suffer from high blood pressure, this study is done in people with mild to moderate high blood pressure to safeguard the use of BAY3283142 in people with CKD in later studies. The main purpose of this study is to learn how safe different single and multiple doses of the study treatment BAY3283142 are compared to placebo in male and female participants (after menopause) with mild to moderate high blood pressure. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the researchers will compare the number of participants who have medical problems after taking BAY3283142 to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once or twice a day. Patients will take one dose for 6 days and will then be switched to a higher dose for additional 6 days. In summary, three different dose combinations consisting of two different doses each will be tested. Participants will be in the study for up to 7 weeks, including 12 treatment days (6 per dose step). They will stay in-house for 17 days starting two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned. During the study, the study team will: - Check vital signs - Take blood and urine samples - Examine the participants' heart health using electrocardiogram (ECG)
The objective of this 3-month observational study was to assess, in 2827 adults, the benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.
This study will evaluate the clinical safety and the performance of the BTL-785F system for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.