Clinical trials: Safety Issues
Safety Issues, Effect of Drug
Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients
- Trial name
- NCT06114641
- Testing
- Enoxaparin sodium injection
- Where
- 3 sites in Indonesia
- Volunteers
- 220 people
- Sponsor
- PT Bio Farma
Motor Vehicle Injury, Safety Issues
Safety-Enhancing Motor Vehicle Child Safety Seat
This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle.
- Trial name
- NCT06384989
- Testing
- Child restraint system with load leg feature
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Minnesota HealthSolutions
Schizophrenia
A Switch Study of BMS-337039 in Schizophrenic Out-patients
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general…
- Trial name
- NCT00232687
- Testing
- Aripiprazole
- Where
- 72 sites in Austria, Belgium and 8 more
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bioavailability, Safety Issues
Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.
- Conditions
- Bioavailability, Safety Issues, Ischemic Cerebrovascular Disease
- Trial name
- NCT03794843
- Testing
- Nimodipine Injection, Nimodipine Injection (II)
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Shenyang Dongxing Pharmaceutical Technology Co., Ltd.
Acquired Bleeding Disorder, Trauma
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
- Trial name
- NCT00124293
- Testing
- activated recombinant human factor VII
- Where
- 2 sites in United States, Canada
- Volunteers
- 63 people
- Sponsor
- Novo Nordisk A/S
Safety Issues
A Phase1 Study of VIB9600
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
- Trial name
- NCT03621605
- Testing
- VIB9600
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Safety Issues, Tolerability
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and…
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT06847698
- Testing
- AVR-48
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AyuVis Research, Inc.
Safety Issues
Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients
This study will test the hypothesis intracoronary administration of OmniMSC-AMI (allogenic bone marrow-derived mesenchymal stem cells) just after finishing the primary percutaneous coronary intervention (PCI) in ST-segment…
- Trial name
- NCT05724576
- Testing
- OmniMSC-AMI
- Where
- Taiwan
- Volunteers
- 1 people
- Sponsor
- Taiwan Bio Therapeutics Inc.
Safety Issues
Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations
To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations.
- Trial name
- NCT03087786
- Testing
- Nicotine Bitartrate Lozenge 4mg, Nicotine Polacrilex 4Mg Lozenge
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Niconovum USA
Safety Issues, Effect of Drug
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
- Trial name
- ADC (NCT06342921)
- Testing
- 15 mg ADC189, 45 mg ADC189
- Where
- China
- Volunteers
- 749 people
- Sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
Type II Diabetes Mellitus, Efficacy, Self
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.
- Conditions
- Type II Diabetes Mellitus, Efficacy, Self, Safety Issues
- Trial name
- EASE (NCT05164263)
- Testing
- Empagliflozin
- Where
- 6 sites in Afghanistan, Kenya and 3 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Getz Pharma
Airway Obstruction, Sedation Complication
Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)
The goal of this four-part preclinical [I-II] and clinical [III-IV] trial is to compare, with randomised crossover study design [I-IV], a new medical airway device with standard procedure (biteblock or no device) for upper airway…
- Conditions
- Airway Obstruction, Sedation Complication, Safety Issues, Patient Satisfaction
- Trial name
- NCT05708651
- Testing
- Investigational device [I-IV], Comparator [I-IV]
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Stairway Medical AB
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
- Trial name
- NCT06053853
- Testing
- Diphtheria Antitoxin
- Where
- Indonesia
- Volunteers
- 68 people
- Sponsor
- PT Bio Farma
Bioequivalency, Safety Issues
Bioequivalence Study of Iron Sucrose Injection in Healthy Participants
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these…
- Trial name
- NCT06674486
- Testing
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer), Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
HIV, Combination Therapy
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or…
- Trial name
- SPARTAN (NCT01332227)
- Testing
- Atazanavir, Ritonavir (heat-stable), Raltegravir
- Where
- 38 sites in United States, France and 5 more
- Volunteers
- 132 people
- Sponsor
- Bristol-Myers Squibb
Safety Issues
A Phase 1 Study of EXT608 in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants.
- Trial name
- NCT05408663
- Testing
- EXT608
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Extend Biosciences Inc.
Healthy
A First-in-Human Study of BNZ132-1-40
This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.
- Trial name
- NCT03046459
- Testing
- BNZ132-1-40
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bioniz Therapeutics
Diaphragm Issues, Ventilator-Induced Lung Injury
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
- Conditions
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- Trial name
- NCT04457427
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- Turkey (Türkiye)
- Sponsor
- Synapse Biomedical
Safety Issues, Tolerance
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo).
- Trial name
- NCT04689035
- Testing
- AVLX-144
- Where
- Finland
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Avilex Pharma