Clinical trials: Delivery Systems
Amenorrhea, Fertility
A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses.
- Conditions
- Amenorrhea, Fertility, Infertility
- Trial name
- NCT07152730
- Testing
- Lutrepulse
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Pneumonia
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well…
- Trial name
- NCT01021436
- Testing
- Amikacin inhalation solution (BAY41-6551)
- Where
- 6 sites in United States, France
- Volunteers
- 30 people
- Sponsor
- Bayer
Asthma
Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate…
- Trial name
- NCT00350207
- Testing
- Tiotropium bromide, Salmeterol xinafoate
- Where
- 109 sites in Austria, Belgium and 12 more
- Volunteers
- 388 people
- Sponsor
- Boehringer Ingelheim
Asthma
A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects
This is a study to compare PK of tezepelumab exposure in healthy subjects by using vial and syringe, APFS, and AI.
- Trial name
- PATH-BRIDGE (NCT03989544)
- Testing
- Tezepelumab
- Where
- Germany
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
ECG Effects
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
- Trial name
- NCT01999114
- Testing
- Buprenorphine transdermal patch, Naltrexone tablet, Moxifloxacin tablet
- Where
- United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Cardiac Glycogenosis, Cardiomyopathy
ATR 1072 in Participants With PRKAG2 Syndrome
ATR 1072 is an investigational medicine being studied in adults with PRKAG2 Syndrome. This study will evaluate the safety of ATR 1072 and how the body processes the drug.
- Conditions
- Cardiac Glycogenosis, Cardiomyopathy, Hypertrophic, Wolff-Parkinson-White Syndrome
- Trial name
- NCT07738107
- Testing
- ATR 1072
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Atrium Therapeutics
Asthma
A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm.
- Trial name
- NCT02150499
- Testing
- levalbuterol tartrate HFA inhalation aerosol
- Where
- 17 sites in United States
- Volunteers
- 18 people
- Sponsor
- Sumitomo Pharma America, Inc.
OTC Deficiency
Clinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) Deficiency
The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels.
- Trial name
- NCT05345171
- Testing
- DTX301, Oral Corticosteroids, Sodium Acetate
- Where
- 16 sites in United States, Argentina and 8 more
- Volunteers
- 37 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Diabetes Mellitus
A Two Part Study of Peroral Insulin in Type 2 Diabetes
Insulin is normally not bioavailable when taken through the oral route, as degradation of the molecule may occur both in the ventricle and in the intestine.
- Trial name
- ORA2 (NCT00990444)
- Testing
- Insulin in Dextran Matrix
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Bows Pharmaceuticals AG
Type 1 Diabetes Mellitus
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)
The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes.
- Trial name
- NCT03743285
- Testing
- AID System, Insulin Lispro
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Eli Lilly and Company
Healthy
Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr
The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc.
- Trial name
- NCT00648414
- Testing
- Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1, Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2, Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Lowe Syndrome
An Open-label, Phase 2 Pilot Study on the Efficacy and Safety of Piclidenoson in Patients With Lowe Syndrome
The primary objective of this trial is to: 1. Evaluate the efficacy of piclidenoson to increase renal uptake of 99mTc-labeled DMSA, in comparison to baseline, after 6 months (26 weeks) of treatment as a measure the reabsorption…
- Trial name
- NCT07410455
- Testing
- Piclidenoson
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- Can-Fite BioPharma
Pharmacokinetics, Hormone Deficiency
Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)
This study was performed to determine the pharmacokinetic parameters of vaginal rings that contain DHEA, testosterone, or combinations of both androgens, in comparison to the oral administration of DHEA and the transdermal…
- Trial name
- NCT03967964
- Testing
- Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg, Testosterone
- Where
- Chile
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Carcinoma, Hepatocellular
Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads Vs. IV Doxorubicin in Treating Liver Cancer
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon.
- Trial name
- NCT00034333
- Testing
- MTC-DOX for Injection
- Where
- 29 sites in United States, Austria and 6 more
- Volunteers
- 240 people
- Sponsor
- FeRx
Needle Stick
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
- Trial name
- NCT02663635
- Testing
- Safe'N'Sound
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nemera La Verpilliere
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Diabetes, Diabetes Mellitus
French Prospective Multicentric Study in Real World
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1 Diabetes
- Trial name
- OPTIMAL-A (NCT07039942)
- Testing
- Omnipod 5
- Where
- 24 sites in France
- Volunteers
- 304 people
- Sponsor
- Insulet Corporation
Otitis Media
Singapore Tympanostomy Tube Delivery System Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis…
- Trial name
- NCT01046877
- Testing
- Tympanostomy Tube Delivery System
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Shigella
Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.
- Trial name
- NCT07049159
- Testing
- ShigETEC vaccine, Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Whooping Cough
Viaskin Pertussis Vaccine Trial
The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the cutaneous route with Viaskin patches to…
- Trial name
- NCT03035370
- Testing
- Viaskin PT 25 mcg, Viaskin PT 50 mcg, Boostrix™
- Where
- Switzerland
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- DBV Technologies