Clinical trials: Single Dose
Spastic Cerebral Palsy
INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)
Prospective, open-label, non-randomized, single-arm, dose titration, phase II study. The study will consist of three injection cycles. In each, an injection visit is followed by an observation period of 12 to 20 weeks.
- Trial name
- INCIPIT (NCT05340439)
- Testing
- IncobotulinumtoxinA 100 UNT [Xeomin]
- Volunteers
- 30 people
- Sponsor
- Universita di Verona
Normal Renal Function, Impaired Renal Function
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal…
- Trial name
- NCT02431481
- Testing
- LEE011
- Where
- 4 sites in United States, Bulgaria and 2 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy
Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20mg/ 25 mg tablets following a single, oral 20/25 mg (1 x 20/25…
- Trial name
- NCT00648011
- Testing
- Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Accuretic™ Tablets 20 mg/25 mg
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Therapeutic Equivalency
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
- Trial name
- NCT01405131
- Testing
- methylprednisolone
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)
This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers.
- Trial name
- NCT01507402
- Testing
- REGN1033(SAR391786)
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Cervical Cancer, Urothelial Carcinoma
- Trial name
- NCT04977453
- Testing
- GI-101, Pembrolizumab (KEYTRUDA®), Lenvatinib
- Where
- 13 sites in United States, South Korea
- Volunteers
- 317 people
- Sponsor
- GI Innovation, Inc.
PAOD - Peripheral Arterial Occlusive Disease, PAD
Recombinant SeV-hFGF2/dF Injection for PAOD
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs.
- Conditions
- PAOD - Peripheral Arterial Occlusive Disease, PAD, Critical Limb Ischemia
- Trial name
- NCT03668353
- Testing
- Recombinant SeV-hFGF2/dF Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Prostate Cancer, Bone Metastases
A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
This study is intended to test an experimental new drug called, EMD 525797 (Study Drug). This drug is not yet approved for sale and has only been tested in a small number of people to date (prior to this study starting another…
- Trial name
- NCT00958477
- Testing
- EMD 525797
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 26 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Advanced Solid Tumors
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors
This study is designed to characterize the absorption, distribution, metabolism and excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C…
- Trial name
- NCT01299701
- Testing
- ASA404
- Where
- New Zealand
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Treatment Of Stenotic Lesions In Native Coronary Arteries.
BioFreedom FIM Clinical Trial.
Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the…
- Trial name
- NCT01172119
- Testing
- Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
- Where
- 4 sites in Germany
- Volunteers
- 182 people
- Sponsor
- Biosensors Europe SA
Healthy
A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes
The purpose of this study is to compare the amount of RAY1225 that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen.
- Trial name
- NCT06577428
- Testing
- RAY1225
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Healthy Participants
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270
This is a randomized, open label, single dose, two-period, crossover trial phase I study. The purpose of this study is to evaluate the food effect on the pharmacokinetics(PK) of SIM0270 after oral administration under fasted…
- Trial name
- NCT06536036
- Testing
- SIM0270
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.
- Trial name
- NCT02018536
- Testing
- GSK2336805 30 mg, GSK2336805 60 mg, GSK2336805 120 mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Schizophrenia
Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers
The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers
- Trial name
- NCT02501109
- Testing
- Aripiprazole
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- CMG Pharmaceutical Co. Ltd
Healthy
Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
- Trial name
- NCT02256709
- Testing
- BIBP 5371 CL tablet, BIBP 5371 CL solution, High fat, high caloric breakfast
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Suicide, Suicidal Ideation
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED).
- Conditions
- Suicide, Suicidal Ideation, Depression
- Trial name
- NCT06085937
- Testing
- Ketamine
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Lindsay Maguire, MD
Diabetes Mellitus, Type 2
Bioequivalence Study for Acarbose/Metformin FDC
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and…
- Trial name
- NCT04065581
- Testing
- Acarbose/Metformin FDC(BAY81-9783), Glucobay, Glucophage
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Impairment
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of…
- Trial name
- NCT05282030
- Testing
- tolebrutinib
- Where
- 4 sites in United States, Germany
- Volunteers
- 22 people
- Sponsor
- Sanofi
COVID-19
Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.
A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the effect, safety and tolerability of LTX-109 administered topically to the anterior nares in subjects with COVID-19 infection.
- Trial name
- NCT04854928
- Testing
- LTX-109 gel, 3%
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Pharma Holdings AS
Hepatic Impairment, Healthy Subjects
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.
- Trial name
- NCT04694365
- Testing
- Fluzoparib
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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