Clinical trials: in Bulgaria
Major Depressive Disorder (MDD)
A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is the EMSAM® TDS.
- Trial name
- NCT07452692
- Testing
- Selegiline Transdermal Delivery System
- Where
- 3 sites in Bulgaria
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Corium Innovations, Inc.
Ulcerative Colitis (UC)
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B).
- Trial name
- NCT06619990
- Testing
- XmAb942
- Where
- 114 sites in United States, Argentina and 17 more
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test…
- Trial name
- GAIA (NCT06475521)
- Testing
- Infant Formula
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 579 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Prostate Cancer
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes.
- Trial name
- NCT07783282
- Testing
- fezolinetant, enzalutamide, apalutamide
- Where
- Bulgaria
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Heart Failure, Atrial Fibrillation (AF)
Cardiovascular Risk in Patients With Primary Hyperparathyroidism
Patients with primary hyperparathyroidism versus healthy controls assessed for their cardiovascular risk and overt CVD
- Conditions
- Heart Failure, Atrial Fibrillation (AF), Arrhythmia, Coronary Artery Disease
- Trial name
- CVD-PHPT (NCT07870369)
- Where
- Bulgaria
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Medical University of Sofia
Impacted Third Molar, Postoperative Pain
Kynurenic Acid and Serotonin as Perioperative Neuroinflammatory Biomarkers in Sequential Third Molar Surgery
A prospective cohort of 40 consecutive patients with bilateral impacted mandibular third molars underwent two sequential surgical extractions separated by a two-week interval.
- Conditions
- Impacted Third Molar, Postoperative Pain, Neuroinflammation, Anxiety
- Trial name
- KYNA-3M (NCT07644065)
- Testing
- Ibuprofen, Ibuprofen + Gabapentin
- Where
- Bulgaria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Plovdiv Medical University
Healthy Volunteers
Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
A clinical trial to investigate the safety and tolerability of single and multiple intranasal (through the nose) dosing with the study drug CHF6467 in 68 healthy adult subjects.
- Trial name
- NCT07163182
- Testing
- CHF6467 Part 1 (SAD), CHF6467 Part 2 (MAD)
- Where
- Bulgaria
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Seasonal Influenza
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase…
- Trial name
- NCT06602024
- Testing
- mRNA-1010, Fluarix®, Influsplit® Tetra
- Where
- 301 sites in United States, Belgium and 9 more
- Volunteers
- 40,805 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Sudden Cardiac Arrest
Research on Attitudes, Confidence, and Practical Skills in Performing Cardiopulmonary Resuscitation and Automated External Defibrillation After Completing a Course Based on the European Resuscitation Council Model
Research on attitudes, confidence, and practical skills in performing cardiopulmonary resuscitation and automated external defibrillation after completing a course based on the European Resuscitation Council model
- Trial name
- RACE-CPR (NCT07331831)
- Where
- Bulgaria
- Volunteers
- 656 people, healthy volunteers welcome
- Sponsor
- First Three Minutes Foundation
Healthy Infants
Efficacy of a New Infant Formula Composition on Gut Health in Infants
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10…
- Trial name
- NCT07242508
- Testing
- Infant Formula, Infant Formula with bioactive ingredients
- Where
- Bulgaria
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Influenza, Human
A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age.
- Trial name
- NCT06087640
- Testing
- aQIV or aTIV, QIV or TIV
- Where
- 255 sites in United States, Australia and 19 more
- Volunteers
- 38,769 people, healthy volunteers welcome
- Sponsor
- Seqirus
Chronic Hepatitis Delta
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants.
- Trial name
- NCT07096193
- Testing
- GS-4321
- Where
- 28 sites in United States, Bulgaria and 7 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Probiotic, Microbiome
Probiotics for Women
Investigation into the effect of probiotic supplementation on the wellbeing of women with a history of vaginal discomfort and/or irritation, along with any microbiome changes.
- Conditions
- Probiotic, Microbiome, Wellbeing
- Trial name
- NCT07364383
- Testing
- Lab4 + Lactobacillus gasseri and Lactobacillus crispatus
- Where
- Bulgaria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cultech Ltd
Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
This was a multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 in participants with chronic hepatic impairment relative to matched participants with normal hepatic…
- Trial name
- NCT06736223
- Testing
- ITF2357
- Where
- 3 sites in Bulgaria, France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Italfarmaco
Type 2 Diabetes, PreDiabetes
Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension
The goal of this hybrid type II effectiveness-implementation trial is to evaluate whether an intersectoral, digitally enabled, family-based intervention can prevent and manage type 2 diabetes mellitus (T2DM) and hypertension…
- Conditions
- Type 2 Diabetes, PreDiabetes, Hypertension, Obesity & Overweight
- Trial name
- DigiCare4You (NCT05648383)
- Testing
- mHealth self-management intervention, Standard care
- Where
- 4 sites in Albania, Bulgaria and 2 more
- Volunteers
- 1,215 people, healthy volunteers welcome
- Sponsor
- Harokopio University
Healthy
Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers
- Trial name
- NCT06502561
- Testing
- Aramchol meglumine, Aramchol free acid
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Galmed Pharmaceuticals Ltd
Chickenpox
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax.
- Trial name
- NCT06693895
- Testing
- Investigational varicella vaccine, Marketed varicella vaccine, Measles, mumps, and rubella vaccine
- Where
- 46 sites in United States, Bulgaria and 6 more
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Inflammation, Oxidative Stress
Reduction of Exposure, Inflammation, and Oxidative Stress Following at Least 2 Years of Switching to THS Use Compared to Cigarette Smoking
This is a cross-sectional 3-group study with subjects enrolled and matched by region (Asia, Europe), age, sex, and average daily product consumption over the last 2 years as self-reported.
- Conditions
- Inflammation, Oxidative Stress, Smoking, Smoking Abstinence
- Trial name
- NCT05385055
- Testing
- THS use, Cigarette smoking, Smoking abstinence
- Where
- 37 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 974 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Moderate to Severe Atopic Dermatitis
A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD).
- Trial name
- NCT07558668
- Testing
- SYX-5219 Oral Capsule
- Where
- 14 sites in United States, Bulgaria and 4 more
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Sitryx Therapeutics Ltd