Clinical trials: Safety Issues
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
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
Safety Issues, Tolerance
Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure.
- Trial name
- NCT06442293
- Testing
- Treatment 1, Treatment 2
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- USANA Health Sciences
Effect of Drugs, Safety Issues
A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）
This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection…
- Trial name
- NCT03120273
- Testing
- Dexlansoprazole Injection, Lansoprazole Injection
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Safety Issues
Effect of Evidence Based Teamwork System on Patient Safety Culture
This study aims to evaluate the effect of evidence-based teamwork system on patient safety culture among newly graduate nurses at Main Mansoura University Hospital
- Trial name
- NCT06117800
- Testing
- TeamSTEPPS
- Where
- Egypt
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Asmaa Elwan Mohammed Hassan
Pharmacokinetics, Safety Issues
Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia)
Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome
- Conditions
- Pharmacokinetics, Safety Issues, Efficacy
- Trial name
- NCT05648799
- Testing
- GP30341 capsules 200 mg, Standard therapy
- Where
- 5 sites in Russia
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Geropharm
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
Colonoscopy, Safety Issues
Motorized Spiral Colonoscopy Trial: A First Feasibility Trial
The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation…
- Conditions
- Colonoscopy, Safety Issues, Adenoma
- Trial name
- MSCT (NCT03000361)
- Testing
- Motorized Spiral Colonoscopy
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Evangelisches Krankenhaus Düsseldorf
Musculoskeletal Disorder, Mental Health Issue
An Integrated Approach to Health, Wellbeing, and Productivity at Work
The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish…
- Conditions
- Musculoskeletal Disorder, Mental Health Issue, Work-related Illness, Safety Issues
- Trial name
- ITASPA (NCT05866978)
- Testing
- Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
- Where
- Denmark
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Holbaek Sygehus
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.
Safety Issues
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.
- Trial name
- NCT03473236
- Testing
- GB002, Generic Dry Powder Inhaler
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Safety Issues
Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose…
- Trial name
- NCT07058779
- Testing
- SSS55
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Tolerance, Safety Issues
Buck Institute Ketone Ester RCT
This study is to investigate the tolerability and safety of a ketone promoting ingredient, called a ketone ester (KE), in healthy older adults.
- Conditions
- Tolerance, Safety Issues, Aging
- Trial name
- BIKE (NCT05585762)
- Testing
- Ketone ester
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Buck Institute for Research on Aging
Safety Issues
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
- Trial name
- NCT04113343
- Testing
- Remimazolam, Alcohol
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Paion UK 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
Pharmacokinetics, Safety Issues
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin®…
- Trial name
- NCT03919448
- Testing
- Bevacizumab
- Where
- Argentina
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Safety Issues, Tolerance
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Trial name
- NCT05217732
- Testing
- ZX-7101A
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Zenshine Pharmaceuticals
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
COVID-19 Vaccine, Safety Issues
ChulaCov19 Vaccine in Healthy Adults
This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants.
- Trial name
- NCT04566276
- Testing
- ChulaCov19 vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
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