Clinical trials: Single Layer
Drug-drug Interaction Study
An Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL®
A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects
- Trial name
- NCT06145217
- Testing
- SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xspray Pharma AB
Bioequivalence
Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions
This bioequivalence study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of propafenone after a single oral dose administration under fasting…
- Trial name
- NCT03915340
- Testing
- Propafenone, Rytmonorm
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Peripheral Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Bioequivalence
Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
This was an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each…
- Trial name
- NCT03702894
- Testing
- Clavamox, Augmentin®
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
Non-steroidal Anti-inflammatory (NSAID), Analgesic
Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet
Randomized, four-way, four-period, fully-replicated, single oral dose, open-label, crossover, bioequivalence study to compare Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) versus Cataflam® 50 coated tablet (50…
- Conditions
- Non-steroidal Anti-inflammatory (NSAID), Analgesic, Antipyretic
- Trial name
- NCT05082662
- Testing
- Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium), Cataflam® 50 coated tablet
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Daclatasvir From Prodactariv 60 mg Film Coated Tablets (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 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 Prodactariv 60 mg F.C.T (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and…
- Trial name
- NCT02780362
- Testing
- Prodactariv, Clatazev
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy Participants
A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
This study is a single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of ammoxetine hydrochloride enteric-coated…
- Trial name
- NCT07508462
- Testing
- Ammoxetine hydrochloride enteric-coated tablets
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Bioequivalence, Ethinylestradiol
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify through a single dose study, if the two…
- Conditions
- Bioequivalence, Ethinylestradiol, Gestodene, Harmonet
- Trial name
- NCT01260805
- Testing
- Reference Drug, Test Drug
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Peripheral Arterial Disease, Peripheral Artery Disease
Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery
- Trial name
- PREVISION (NCT05556681)
- Testing
- BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
- Where
- 10 sites in Australia, New Zealand and 1 more
- Volunteers
- 34 people
- Sponsor
- C. R. Bard
Pressure Ulcer, Ulcer, Pressure
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.
- Conditions
- Pressure Ulcer, Ulcer, Pressure, Pressure Wound, Pressure Area
- Trial name
- NCT07126886
- Testing
- Standard of Care, XPURT + SOC
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Applied Biologics, LLC
Healthy
Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)
Comparative randomized, single dose Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules…
- Trial name
- NCT05038969
- Testing
- Stomopral, Nexium
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Bioequivalence, Healthy Subjects
Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC…
- Trial name
- NCT05464745
- Testing
- PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets, Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
- Where
- Jordan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Bioequivalence
Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions
This is an open-labeled, randomized, four period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Plavix®, 75 mg film-coated tablets) or the test…
- Trial name
- NCT05934799
- Testing
- Clopidogrel film-coated tablet 75 mg, Plavix® film-coated tablet 75 mg
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Disk Herniated Lumbar, Disc Disease Degenerative
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
- Conditions
- Disk Herniated Lumbar, Disc Disease Degenerative, Spondylolisthesis
- Trial name
- PRINTLIF (NCT05237908)
- Testing
- Transforaminal Lumbar Interbody Fusion
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Aesculap AG
Healthy
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
- Trial name
- NCT02767310
- Testing
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
Hypercholesterolaemia, Mixed Dyslipidaemia
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.
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.
- Conditions
- Hypercholesterolaemia, Mixed Dyslipidaemia, Cardiovascular Diseases
- Trial name
- NCT06923956
- Testing
- Bempedoic Acid Film Coated Tablet, Nilemdo® (Bempedoic Acid) Film-coated tablets
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence, Diabetes Mellitus, Type 2
Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed…
- Trial name
- NCT05549570
- Testing
- Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Peripheral Artery Disease (PAD)
Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries
The Rontis Drug Coated - Peripheral Balloon Catheter is intended for PTA procedure on atherosclerotically stenotic or obstructed vessels and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis…
- Trial name
- NCT04821388
- Testing
- Rontis DCB
- Where
- 5 sites in Greece
- Volunteers
- 30 people
- Sponsor
- Rontis Hellas SA