Clinical trials: Safety Issues
Safety Issues
Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers
This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers.
- Trial name
- NCT05004571
- Testing
- EQU-001
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Equilibre Biopharmaceuticals B.V.
Safety Issues, Patient Care
Survey of Housestaff Attitudes Toward Patient Care and Safety
Background: The occurrence of medical errors and their deleterious effects on quality of care delivered are widely recognized phenomena in healthcare today.
- Trial name
- NCT00845052
- Where
- United States
- Volunteers
- 674 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Effect of Drugs, Safety Issues
PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers
The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.
- Trial name
- NCT03488186
- Testing
- Lansoprazole Capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Drug Drug Interaction, Safety Issues
Possible Effects of Propylthiouracil, Riociguat and Perphenazine on Circulation of Healthy Volunteers
This trial is part of the Horizon 2020 project, REPO-TRIAL, on in-silico, mechanism-based drug repurposing in high unmet-medical-need indications.
- Trial name
- REPO-STROKE1 (NCT04776499)
- Testing
- Propylthiouracil, Riociguat, Perphenazine
- Where
- Germany
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Maastricht University
Toxicity, Safety Issues
Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity.
- Trial name
- NCT03663881
- Testing
- P2Et extract
- Where
- Colombia
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario San Ignacio
Healthy, Safety Issues
Assessing the Effects of a Cannabidiol Derived From Hemp Supplement in Healthy Adults
The purpose of this prospective, randomized, double-blind, placebo-controlled trial is to assess the physiological, biochemical, and psychometric impacts of a brand-specific hemp-derived cannabidiol product in a sample of healthy…
- Trial name
- NCT05212402
- Testing
- Cannabinol
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Safety Issues
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU).
- Trial name
- NCT03585192
- Testing
- Skin Group, Warmer Group
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Effect of Drugs, Safety Issues
Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer
The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.
- Trial name
- NCT03488173
- Testing
- Lansoprazole capsules
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Safety Issues
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
Five healthy participants with normal sperm counts and motility will ingest increasing doses of celastrol over a period of several days.
- Trial name
- NCT05413226
- Testing
- Celastrol
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Legend Labz, Inc.
Safety Issues
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
This study is to assess the safety of Vi-DT vaccine in adults and children.
- Trial name
- NCT03109600
- Testing
- Vi-DT (Bio Farma), Vi polysaccharide vaccine, Influenzae vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
The goal of this clinical trial is to learn if RG002C0106 is safe in healthy participants . It will also learn about how the drug is absorbed, distributed， metablized and excrited.
- Trial name
- NCT07902245
- Testing
- RG002C0106, 0.9% sodium chloride injection
- Where
- Austria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Safety Issues, Tolerance
Safety and Tolerability of Soy Fiber
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
- Trial name
- NCT04499482
- Testing
- Food
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Child Development, Father-Child Relations
A Quasi-experimental Evaluation of the Malezi Program in Tanzania
The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable.
- Conditions
- Child Development, Father-Child Relations, Knowledge, Attitudes, Practice, Safety Issues
- Trial name
- Malezi II (NCT05244161)
- Testing
- RMV-ECD
- Where
- Tanzania
- Volunteers
- 1,248 people, healthy volunteers welcome
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Safety Issues
Paracetamol Hypothermia Children
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
- Trial name
- NCT04608669
- Testing
- Paracetamol
- Where
- Lebanon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saint George Hospital
Mental Health Issue, Anxiety Disorders
Delivering ICBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel
Public safety personnel (PSP) have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder (PTSD).
- Conditions
- Mental Health Issue, Anxiety Disorders, Depressive Disorder, Post-Traumatic Stress Disorder
- Trial name
- NCT04666974
- Testing
- iCBT, In-Person CBT
- Where
- Canada
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Dr. Nazanin Alavi
Safety Issues
Tolerance of a Probiotic Formula
Evaluate the tolerance of a probiotic formula in infants
- Trial name
- NCT03925558
- Testing
- Probiotics
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Probi AB
Safety Issues, Pharmacokinetics
Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
- Trial name
- HTL0018318 (NCT03198624)
- Testing
- HTL0018318
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Safety Issues, Infant Nutrition Disorders
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
- Trial name
- NCT03035721
- Testing
- Low protein formula, Standard protein formula
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Safety Issues, Immunogenicity
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
- Trial name
- NCT03460405
- Testing
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Tolerance
Study to Evaluate LPH-5 in Healthy Subjects
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
- Trial name
- NCT06722820
- Testing
- LPH-5
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Lophora