Clinical trials: Single Dose
Attention Deficit Hyperactivity Disorder
Pharmacokinetics of Two Extended-Release Formulations of Methylphenidate in Children With Attention Deficit Hyperactivity Disorder (ADHD)
This study is designed to provide pharmacokinetic data for the assessment of bioequivalence of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy measures.
- Trial name
- MPH-Kinetics (NCT00772161)
- Testing
- Methylphenidate
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- University Hospital Freiburg
Beta-Thalassemia, Thalassemia
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Transfusion-Dependent β-Thalassemia (TDT)
This is a single-dose, open-label study in pediatric participants with TDT. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (CTX001).
- Conditions
- Beta-Thalassemia, Thalassemia, Genetic Diseases, Inborn, Hematologic Diseases
- Trial name
- NCT05356195
- Testing
- CTX001
- Where
- 6 sites in United States, Canada and 3 more
- Volunteers
- 16 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Asthma in Children
Double Dose Magnesium Sulphate in Moderate-severe Asthma in Paediatrics
Introduction : . In Oman the prevalence of asthma was estimated to be 7.3% of adults and 12.7% of children . Magnesium sulphate is the second line treatment, many studies had shown that it has beneficial effect in treating acute…
- Trial name
- NCT04465175
- Testing
- Magnesium Sulfate
- Volunteers
- 90 people
- Sponsor
- Oman Medical Speciality Board
MPS IIIA, Sanfilippo Syndrome
Gene Transfer Study of ABO-102 in Patients With Middle and Advanced Phases of MPS IIIA Disease
Open-label, clinical trial of scAAV9.U1a.hSGSH injected intravenously through a peripheral limb vein
- Conditions
- MPS IIIA, Sanfilippo Syndrome, Sanfilippo A, Mucopolysaccharidosis III
- Trial name
- NCT04088734
- Testing
- ABO-102
- Where
- 3 sites in United States, Australia and 1 more
- Volunteers
- 5 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Dental Pain
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the…
- Trial name
- NCT01960114
- Testing
- Acetaminophen ER
- Where
- United States
- Volunteers
- 403 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
GM1 Gangliosidosis, GM1 Gangliosidosis, Type I
Study of Safety, Tolerability and Efficacy of PBGM01 in Pediatric Participants With GM1 Gangliosidosis
PBGM01 is a gene therapy for GM1 gangliosidosis intended to deliver a functional copy of the GLB1 gene to the brain and peripheral tissues.
- Conditions
- GM1 Gangliosidosis, GM1 Gangliosidosis, Type I, GM1 Gangliosidosis, Type 2, Beta-Galactosidase-1 (GLB1) Deficiency
- Trial name
- Imagine-1 (NCT04713475)
- Testing
- PBGM01
- Where
- 7 sites in United States, Brazil and 2 more
- Volunteers
- 26 people
- Sponsor
- Gemma Biotherapeutics
Plasmodium Falciparum
Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes
The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with…
- Trial name
- NCT02090036
- Testing
- Primaquine (For artemether-lumefantrine+primaquine arm)
- Where
- Tanzania
- Volunteers
- 220 people
- Sponsor
- Muhimbili University of Health and Allied Sciences
HIV Infections
Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV.
- Trial name
- P1060 (NCT00307151)
- Testing
- Lamivudine, Lopinavir/ritonavir, Nevirapine
- Where
- 10 sites in India, Malawi and 5 more
- Volunteers
- 452 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Duchenne Muscular Dystrophy
A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy
This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with…
- Trial name
- NCT03362502
- Testing
- PF-06939926
- Where
- 22 sites in United States
- Volunteers
- 23 people
- Sponsor
- Pfizer
Postoperative Nausea and Vomiting
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in…
- Trial name
- NCT01395901
- Testing
- Palonosetron, Ondansetron
- Where
- 44 sites in United States, Argentina and 6 more
- Volunteers
- 670 people
- Sponsor
- Helsinn Healthcare SA
Participants Less Than 12 Months of Age With RSV Illness
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory…
- Trial name
- NCT00435227
- Testing
- Motavizumab
- Where
- 31 sites in United States
- Volunteers
- 12 people
- Sponsor
- MedImmune LLC
Escherichia Coli Diarrhea
Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
- Trial name
- ETVAX/dmLT (NCT02531802)
- Testing
- ETVAX, dmLT, Bicarbonate Buffer
- Where
- Bangladesh
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- PATH
Pulmonary Arterial Hypertension
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=)…
- Trial name
- NCT03492177
- Testing
- selexipag (Uptravi)
- Where
- 34 sites in United States, Belarus and 14 more
- Volunteers
- 63 people
- Sponsor
- Actelion
Asthma
Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)
To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in pediatric asthma patients ages 6 to less than 12 years.
- Trial name
- NCT00751413
- Testing
- Comparator: MK0633
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC
Neurogenic Detrusor Overactivity, Overactive Bladder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
The purpose of this study is to evaluate the pharmacokinetics as well as the safety and tolerability of mirabegron OCAS tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.
- Conditions
- Neurogenic Detrusor Overactivity, Overactive Bladder, Pharmacokinetics of Mirabegron
- Trial name
- NCT02211846
- Testing
- Mirabegron
- Where
- 13 sites in Belgium, Denmark and 3 more
- Volunteers
- 34 people
- Sponsor
- Astellas Pharma Inc
Uncomplicated Plasmodium Falciparum Malaria
Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients > 0.5 years and <= 70 years of age with…
- Trial name
- NCT02083380
- Testing
- Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, Artefenomel 800mg: piperaquine 1440mg
- Where
- 9 sites in Benin, Burkina Faso and 5 more
- Volunteers
- 448 people
- Sponsor
- Medicines for Malaria Venture
Pain, Fever
Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates
The purpose of this study is triple, i.e. document single dose pharmacokinetics and -dynamics of intravenous paracetamol in preterm and term neonates after a loading dose (20 mg/kg iv bolus paracetamol), document multiple dose…
- Trial name
- PARANEO (NCT00969176)
- Testing
- paracetamol
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Pertussis
2-year Follow-up After a Single Dose Acellular Pertussis Vaccination
In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccined) manufactured by BioNet-Asia Co., Ltd.
- Trial name
- NCT04113655
- Testing
- Pertagen (aP BioNet), Boostagen (TdaP BioNet), Adacel
- Where
- 2 sites in Thailand
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Asthma
Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100…
- Trial name
- NCT01772368
- Testing
- Fp MDPI, FS MDPI, Advair Diskus
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Malaria
Single Low-dose Primaquine Efficacy and Safety.
Background: The World Health Organization has recommended addition of a 0.25 mg/kg single-dose primaquine (PQ) to standard artemisinin-based combination therapy (ACT) for elimination of malaria in low transmission-settings and…
- Trial name
- ESSLDPQP4502D6 (NCT03352843)
- Testing
- Primaquine
- Where
- Tanzania
- Volunteers
- 157 people
- Sponsor
- Tropical Pesticides Research Institute, Tanzania