Clinical trials: Drug Safety
Influenza, Acute Respiratory Viral Infections
Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions.
This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following…
- Trial name
- NCT07645534
- Testing
- Ingavirin forte, capsules, 90 mg + 20 mg, Ingavirin, capsules, 90 mg
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Chronic Renal Failure, Chronic Kidney Disease
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- EMERALD 1 (NCT00597753)
- Testing
- peginesatide, Epoetin Alfa
- Where
- 89 sites in United States
- Volunteers
- 803 people
- Sponsor
- Affymax
Drusgs for IBD
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes
This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included.
- Trial name
- NCT06337565
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Peripheral Arterial Disease
Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.
In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter…
- Trial name
- NCT05670171
- Testing
- Debulking Atherectomy, Stent Angioplasty
- Where
- 10 sites in China
- Volunteers
- 244 people
- Sponsor
- Xuanwu Hospital, Beijing
Butylphthalide, Cardiac Arrest
Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)
Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain.
- Conditions
- Butylphthalide, Cardiac Arrest, Neuroprotective Drugs
- Trial name
- NCT06353334
- Testing
- Butylphthalide and Sodium Chloride Injection, Saline Solution
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tang Ziren
Drug Interaction
DDI Study Between Dorzagliatin and Rifampicin
The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.
- Trial name
- NCT04080609
- Testing
- Dorzagliatin
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Hua Medicine Limited
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy Adults
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-07999415) in healthy adult participants.
- Trial name
- NCT06965465
- Testing
- PF-07999415
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
GERD, EPS
Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS
Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or epigastric pain
- Trial name
- NCT03238534
- Testing
- Neobianacid®, Omeprazole 20mg
- Where
- 12 sites in Italy
- Volunteers
- 275 people
- Sponsor
- Aboca Spa Societa' Agricola
Tuberculosis, Pre-XDR-TB
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid…
- Conditions
- Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04062201
- Testing
- Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form
- Where
- 2 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Wits Health Consortium (Pty) Ltd
Partial Onset Seizures
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
- Trial name
- NCT01147003
- Testing
- Investigational new drug, company code: BGG492
- Where
- 51 sites in United States, Bulgaria and 8 more
- Volunteers
- 93 people
- Sponsor
- Novartis
Drug-Drug Interaction
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
This study will be an open-label, parallel-arm study to determine if a prior intra-articular (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or pharmacokinetics (PK) of a subsequent IA injection of the…
- Trial name
- NCT04598542
- Testing
- Lorecivivint (LOR), Triamcinolone acetonide (TA)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Biosplice Therapeutics, Inc.
Healthy Volunteers
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants
The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures similar to the capsule…
- Trial name
- NCT05303220
- Testing
- Branebrutinib
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Cardiac Disease
A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV…
- Trial name
- NCT04185246
- Testing
- NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Echocardiogram
- Where
- 2 sites in Taiwan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Trust Bio-sonics, Inc.
ACNE VULGARIS
A Novel Combination Oral Agent to Treat Acne Vulgaris
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females
- Trial name
- NCT01301586
- Testing
- Doxycycline and S-equol, Doxycycline
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nexgen Dermatologics, Inc.
Aspergillosis
MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)
Invasive aspergillosis is a type of fungal infection typically identified in very sick patients (for example, patients with cancer or who have had a bone marrow or organ transplant).
- Trial name
- NCT00076869
- Testing
- MK0991, caspofungin acetate, Comparator: amphotericin B, Comparator: lipid formulation of amphotericin B and/or azole
- Volunteers
- 55 people
- Sponsor
- Merck Sharp & Dohme LLC
Stargardt
The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4
To evaluate the preliminary safety of monocular and single subretinal injection of ZVS106e injection in the treatment of patients with hereditary retinal degeneration (ABCA4-IRDS) caused by ABCA4 biallelic mutations.
- Trial name
- ZVS106e (NCT07241169)
- Testing
- ZVS106e
- Where
- 2 sites in China
- Volunteers
- 9 people
- Sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Rosacea
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
- Trial name
- NCT03689010
- Testing
- Azelaic acid foam 15%, Finacea® (Azelaic acid Foam) 15%, Vehicle of the test product
- Where
- United States
- Volunteers
- 1,116 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Anemia in Incident Dialysis Patients
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
- Trial name
- Himalayas (NCT02052310)
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 1,043 people
- Sponsor
- Kyntra Bio
Senescence Wrinkles, Acne, Pitting Scar
Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting…
- Trial name
- NCT02698813
- Testing
- umbilical cord mesenchymal stem cells and hyaluronic acid, hyaluronic acid
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
Smoking
Exploratory THS 2.1 Nicotine Pharmacokinetics and Safety Study
The main goal of this exploratory study is to evaluate the pharmacokinetic profile of nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional cigarettes (CC).
- Trial name
- NCT01780688
- Testing
- Conventional cigarettes (CC), THS 2.1
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.