Clinical trials: Safety Issues
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
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
- Trial name
- NCT05580172
- Testing
- RH324
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ReHeva Biosciences,Inc.
GERD, Cardiac Event
Cardiac Safety of Lansoprazole and Domperidon Combination
The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name: Lasotab) in GERD patients…
- Conditions
- GERD, Cardiac Event, Safety Issues
- Trial name
- NCT03355170
- Testing
- Lansoprazole/Domperidone, Lansoprazole
- Where
- 16 sites in Turkey (Türkiye)
- Sponsor
- Neutec Ar-Ge San ve Tic A.Ş
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
Direct Acting Anti-Viral's In Chronic HCV Patients
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated…
- Trial name
- NCT04664894
- Testing
- Sofosbuvir
- Where
- Pakistan
- Volunteers
- 511 people
- Sponsor
- Getz Pharma
Safety Issues, Pharmacokinetics
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong…
- Conditions
- Safety Issues, Pharmacokinetics, Drug Interaction, Tolerability
- Trial name
- NCT05633147
- Testing
- Linaprazan glurate, Drug drug interaction (DDI) - Clarithromycin (Part I), Drug drug interaction (DDI) - Midazolam (Part 2)
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
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
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
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
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
The purpose of this study was to determine the safety and tolerability of PH100, a purified phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds 8,8'-bieckol, dieckol, and…
- Trial name
- NCT04335045
- Testing
- PH100 100mg, PH100 200mg, PH100 400mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Phloronol Inc.
Safety Issues
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
- Trial name
- NCT03565861
- Testing
- NP10679
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Neurop Inc.
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
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants.
- Trial name
- NCT04140604
- Testing
- Lactobacillus salivarius AP-32, Bifidobacterium animalis subsp. lactis CP-9
- Where
- Taiwan
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Hsieh-Hsun Ho
Safety Issues, Tolerance
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in…
- Conditions
- Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
- Trial name
- NCT05427253
- Testing
- C106 solution
- Where
- Sweden
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vicore Pharma AB
Safety Issues
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
- Trial name
- NCT04485481
- Testing
- ADX-914
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Q32 Bio Inc.
Pharmacokinetics, Safety Issues
PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
- Conditions
- Pharmacokinetics, Safety Issues, Bleeding
- Trial name
- NCT05041699
- Testing
- IPM Ring-105, IPM Ring-106
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Safety Issues
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
- Trial name
- NCT03336593
- Testing
- Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
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.
Bone Regeneration, Safety Issues
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as…
- Trial name
- NCT06383377
- Testing
- Tooth extraction and bone graft procedure
- Where
- 5 sites in Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Wishbone SA
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