Clinical trials: Single Layer
Arthritis
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
- Trial name
- NCT00749385
- Testing
- PN 400, EC naproxen plus EC esomeprazole, EC naproxen
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- POZEN
Patients With Peripheral Artery Disease in the SFA or PA
First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries
The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions…
- Trial name
- NCT02941224
- Testing
- SELUTION DCB (sirolimus coated balloon)
- Where
- 4 sites in Germany
- Volunteers
- 50 people
- Sponsor
- M.A. Med Alliance S.A.
Healthy
A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers
This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.
- Trial name
- NCT03697889
- Testing
- Naproxen sodium (test product), Naproxen sodium (reference product)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Coronary Artery Disease
Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent
The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm…
- Trial name
- Evolve (NCT01135225)
- Testing
- PROMUS(TM) Element (TM) Stent System, Evolution Stent System
- Where
- 29 sites in Australia, Belgium and 7 more
- Volunteers
- 291 people
- Sponsor
- Boston Scientific Corporation
Rheumatoid Arthritis (RA)
Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in…
- Trial name
- NCT07266207
- Testing
- ARD-885 Tablets
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Artivila (Shenzhen) Innovation Center, Ltd
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 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
- NCT06124547
- Testing
- Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Hypercholesterolaemia
Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07170852
- Testing
- Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Femoral Artery Occlusion, Femoral Arterial Stenosis
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
- Trial name
- NCT02013271
- Testing
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
- Where
- 14 sites in Austria, Belgium and 3 more
- Volunteers
- 125 people
- Sponsor
- C. R. Bard
Iron Overload
Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis
This study employed a prospective, single-arm, global multi-center interventional open-label, non-randomized design to identify and assess safety profile of the crushed deferasirox FCT when administered up to 24 weeks in…
- Trial name
- MIMAS (NCT03372083)
- Testing
- Deferasirox
- Where
- 10 sites in Egypt, Italy and 5 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Pharmacokinetic Analysis, Bioequivalence
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
Pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, bioequivalence study of Levetiracetam 1500 mg coated granules in sachet formulations and Keppra (Levetiracetam) 2 x…
- Conditions
- Pharmacokinetic Analysis, Bioequivalence, Health Adult Subjects
- Trial name
- NCT07393022
- Testing
- Levetiracetam 1500 mg, Keppra® 750 mg
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Desitin Arzneimittel GmbH
Femoral Artery Stenosis, Popliteal Artery Stenosis
Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries
The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- LEVANT 2 (NCT01412541)
- Testing
- Standard Uncoated Angioplasty Balloon, Moxy Drug Coated Balloon
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 532 people
- Sponsor
- C. R. Bard
Fever, Pain
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and…
- Trial name
- NCT06855576
- Testing
- Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- HALEON
Dysfunctional AV Graft, Dysfunctional AV Fistula
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.
- Trial name
- ACCESS (NCT02183194)
- Testing
- Lutonix Paclitaxel Drug Coated Balloon
- Where
- 4 sites in Austria, Germany
- Sponsor
- C. R. Bard
Healthy Participants
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma
The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites: Viatris and Neolpharma by…
- Trial name
- NCT06205407
- Testing
- Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris, Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma.
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer
Femoral Arterial Stenosis, Stenosis of Popliteal Arteries
LEVANT Japan Clinical Trial
To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.
- Conditions
- Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion, Occlusion of Popliteal Arteries
- Trial name
- NCT01816412
- Testing
- MD02-LDCB Paclitaxel coated balloon catheter, Standard Uncoated Balloon Angioplasty Catheter
- Where
- Japan
- Volunteers
- 110 people
- Sponsor
- C. R. Bard
Healthy
A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.
- Trial name
- NCT05319912
- Testing
- ALXN1840 Enteric-coated Tablet, ALXN1840 Non-coated Capsule, Omeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.
- Trial name
- NCT05319899
- Testing
- ALXN1840, Omeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Bioequivalence
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 20 mg in Healthy Male Volunteers Under Fed 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®, 20 mg film-coated tablets) or the test…
- Trial name
- NCT04729998
- Testing
- Rivaroxaban film-coated tablet 20 mg, Xarelto® film-coated tablet 20 mg
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention
Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
This study aimes to compare the clinical outcomes of drug-coated balloon-based percutaneous coronary intervention (DCB-based PCI) and drug-eluting stent-based percutaneous coronary intervention (DES-based PCI) in patients with…
- Trial name
- DCBMultivessel (NCT07539324)
- Testing
- GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter), Contemporary Drug-Eluting Stents (DES)
- Where
- South Korea
- Volunteers
- 892 people
- Sponsor
- Genoss Co., Ltd.
Healthy
to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.
- Trial name
- NCT01926548
- Testing
- CJ Imatinib mesylate tablet, Gleevec film-coated tablet 2 x 100mg
- Where
- South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation