Clinical trials: Single Layer
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon
PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due…
- Trial name
- PREVEIL (NCT02648620)
- Testing
- SurVeil Drug Coated Balloon, Angioplasty
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- SurModics, Inc.
Gastrointestinal Diseases, Laparotomy
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial.
- Conditions
- Gastrointestinal Diseases, Laparotomy, Anastomosis, Surgical, Absorbable, Coated Sutures
- Trial name
- NCT00645684
- Testing
- Gastrointestinal Anastomosis
- Where
- 3 sites in Hungary
- Volunteers
- 210 people
- Sponsor
- Aesculap AG
Hyperlipidemias
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
- Trial name
- NCT06225635
- Testing
- Ezerosu(monolayer tablet), Ezerosu(double layer tablet)
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Kidney Transplantation
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
- Trial name
- NCT00154206
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Artery Disease
Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.
- Trial name
- LATITUDE (NCT03471234)
- Testing
- Angioplasty
- Where
- 2 sites in Brazil
- Volunteers
- 299 people
- Sponsor
- Scitech Produtos Medicos SA
Type2diabetes
Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus…
- Trial name
- NCT06450262
- Testing
- Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets, Synjardy® 12.5mg/1000mg film-coated tablets
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose…
- Trial name
- NCT06124573
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Bioequivalence
Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions
This study is designed in accordance with the European Medicines Agency (EMA) regulatory guidelines, with the aim of characterizing the bioavailability of febuxostat in the two formulations in healthy adult subjects.
- Trial name
- NCT03918551
- Testing
- Febuxostat, Adenuric
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to…
- Trial name
- NCT01504984
- Testing
- SYO-1126, Glivec film coated tab 4T(400mg)
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Samyang Biopharmaceuticals Corporation
Hepatitis B
Pharmacokinetics of Two Formulations of Entecavir
A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent Dose of a Reference Drug Product (Baraclude 0.5mg…
- Trial name
- NCT02850848
- Testing
- Entigin Film Coated Tablet 0.5mg, (Baraclude 0.5mg Tablets
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Healthy
Bioavailability of BIBR 953 ZW in Healthy Subjects
To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.
- Trial name
- NCT02170766
- Testing
- BIBR 1048 low1, BIBR 1048 low2, BIBR 1048 medium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Participants, Participants With Moderate Renal Impairment
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function
This study is a single-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants…
- Trial name
- NCT07694869
- Testing
- ammoxetine hydrochloride enteric-coated tablets
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Peripheral Artery Disease
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or…
- Trial name
- PK (NCT01912937)
- Testing
- Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
- Where
- 2 sites in New Zealand
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Healthy
Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European Egyptian Pharmaceutical Industries, Egypt) versus…
- Trial name
- NCT02675127
- Testing
- Daktavira, Daklinza
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Bioavailability of BIBR 1048 MS Tablets in Healthy Subjects With or Without Food
Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food
- Trial name
- NCT02170922
- Testing
- BIBR 1048 MS tablet, BIBR 1048 MS solution
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
COVID-19, Coronavirus Pneumonia
A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects
This study is divided into two parts, including Part I: a randomized, open-label, positive drug-controlled, single ascending dose (SAD) study, a food effect (FE) study, and Part II: a randomized, double-blind, placebo-controlled…
- Trial name
- NCT06860282
- Testing
- Remdesivir, CX2101A
- Where
- China
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Heronova Pharmaceuticals
Healthy
A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)
24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized, crossover, self-control method, with…
- Trial name
- NCT02316730
- Testing
- Sanchi-Tongshu Capsule (Enteric coated pellets), Sanchi-Tongshu Capsule
- Where
- China
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
Healthy
A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.
This study will estimate the effect of food and the proton pump inhibitor, esomeprazole on the pharmacokinetics of crizotinib in a coated microsphere formulation.
- Trial name
- NCT03137134
- Testing
- Crizotinib, Esomeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer