Clinical trials: Single Layer
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries
The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.
- Trial name
- NCT02717104
- Where
- 16 sites in South Korea
- Volunteers
- 249 people
- Sponsor
- C. R. Bard
Arteriovenous Fistula
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and…
- Trial name
- AVPAS (NCT03506308)
- Testing
- LUTONIX 035 Drug Coated Balloon PTA Catheter
- Where
- 26 sites in United States, Canada
- Volunteers
- 213 people
- Sponsor
- C. R. Bard
Bioequivalence
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test…
- Trial name
- NCT04753489
- Testing
- Rivaroxaban film-coated tablet 10 mg, Xarelto® film-coated tablet 10 mg
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Relative Bioavailability of BI 671800 HEA in Healthy Male Volunteers
To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline) administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as solution to the jejunum, ascending or…
- Trial name
- NCT02222233
- Testing
- BI 671800 HEA delayed release (enteric coated) tablet, BI 671800 HEA solution, BI 671800 HEA particulate
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Heart Transplantation
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
- Trial name
- NCT00574743
- Testing
- Enteric-coated Mycophenolate Sodium
- Where
- 9 sites in United States, Argentina and 2 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Bioequivalence
The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions.
This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan in the two formulations in healthy subjects.
- Trial name
- NCT03951051
- Testing
- Olmesartan Medoxomil 40 mg, Olmetec®
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Gastroesophageal Reflux
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
- Trial name
- NCT00259012
- Testing
- pantoprazole sodium enteric-coated spheroid suspension
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 67 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03706300
- Testing
- Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence, Type 2 Diabetes
Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers
The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.
- Trial name
- NCT05549583
- Testing
- Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Epilepsy
Bioequivalence Study of Perampanel Tablets 12 mg
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 12 mg film-coated tablets…
- Trial name
- NCT06450223
- Testing
- Perampanel 12 MG, Fycompa 12 mg film-coated tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy Subjects
Comparison of Two Dose Strengths of Selexipag in Healthy Adults
Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
- Trial name
- NCT02745860
- Testing
- Selexipag (adult formulation), Selexipag (pediatric formulation)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Actelion
Pulmonary Arterial Hypertension (PAH)
Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)
Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400…
- Trial name
- NCT06932198
- Testing
- Selexipag Film Coated Tablets, Uptravi® Film Coated Tablets
- Where
- Jordan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
1. Investigational Product 1. Imatinib mesylate tablet 400 mg 2. Glivec film-coated tablet 100 mg (Comparator) 2. Expected target disease 1. chronic myeloid leukemia 2. Gastrointestinal stromal tumors 3.
- Trial name
- NCT01751919
- Testing
- Imatinib mesylate tablet 400 mg, 1 Tablet, Glivec film-coated tablet 100 mg, 4 Tablets
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Angiopathy, Peripheral
- Trial name
- SIGNATURE (NCT04971772)
- Where
- 11 sites in Brazil, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Cardionovum GmbH
Healthy
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in…
- Trial name
- NCT01132183
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Peripheral Artery Disease
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions…
- Trial name
- NCT02278991
- Testing
- Lutonix Drug Coated Balloon
- Where
- 12 sites in Germany, Greece and 1 more
- Volunteers
- 149 people
- Sponsor
- C. R. Bard
Mental Competency, Mental Fatigue
Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue
To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and allevi ating mental and physical stress in healthy male and female subjects leading demanding lifestyles.
- Trial name
- NCT00144235
- Testing
- Pharmaton PHL 00749
- Where
- United Kingdom
- Volunteers
- 412 people
- Sponsor
- Boehringer Ingelheim
Healthy
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
- Trial name
- NCT02170792
- Testing
- BIBR 1048 MS, Ranitidine
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim