Clinical trials: Single Layer
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.
Healthy
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
- Trial name
- NCT05303324
- Testing
- ALXN1840
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Prostatic Hyperplasia
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry.
- Trial name
- NCT01495026
- Testing
- Dutasteride (0.5mg, fasted state), Dutasteride (0.5mg, fed state), Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants.
- Trial name
- NCT04314037
- Testing
- Cesol (Test), Biltricide (Reference)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Quality of Health Care, Patient Safety
CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans
This trial evaluates CITE, a retrieve-and-verify layer that audits an AI-generated care plan against a full-text evidence corpus and flags patient-specific codifiable safety hazards to the clinician.
- Conditions
- Quality of Health Care, Patient Safety, Clinical Decision Support
- Trial name
- CITE (NCT07718893)
- Testing
- CITE evidence-grounding retrieve-and-verify layer, AI care plan with safety guardrails
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Waymark
Surface Roughness and Thickness Clear Aligner Sheat
Evaluation of Physical Changes in Single-Layer and Multi-Layer Clear Aligners
aim of the study: to evaluate and compare the surface roughness (Ra, Rq, Rz), Vickers microhardness (VHN), and thickness of single-layer and multi-layer clear aligner sheets.
- Trial name
- NCT07449598
- Testing
- clear aligner
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Mansoura University
Infections, Urinary Tract
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration.
- Trial name
- NCT02446496
- Testing
- Cefadroxil tablets manufactured by GSK, Cefadroxil tablets manufactured by NP
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer
The Bioequivalence Study of Linagliptin 5 mg Film-coated Tablet in Healthy Thai Volunteers
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablet (LINIPTIN) and Reference Product (Trajenta®) in Healthy Thai Volunteers under Fasting Conditions
- Trial name
- NCT06243809
- Testing
- Linagliptin 5 mg Oral Tablet, Trajenta 5 MG Oral Tablet
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- International Bio service
Pain
Relative Bioavailability and Food Effect Study
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used.
- Trial name
- NCT00827515
- Testing
- PH797804
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
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
Schizophrenia
Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)
Single dose oral bioequivalence study of Brexpiprazole 4 mg Film Coated Tablets and RXULTI® (Brexpiprazole) 4 mg film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07266792
- Testing
- Brexpiprazole Film Coated Tablets, RXULTI film coated tablet
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Osteoarthritis
RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem
The Trident Tritanium acetabular component of a total hip prosthesis is a new developed uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup will be compared with the Trident HA acetabular…
- Trial name
- RSA (NCT01618084)
- Testing
- Tritanium acetabular component
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Maastricht University Medical Center
Obstructive Pulmonary Function, Restrictive Pulmonary Function
Study to Compare the Pharmacokinetics and Pharmacodynamics of ASA Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function
The goal of this clinical trial is to compare the pharmacokinetics (PK) pharmacodynamics (PD), safety and tolerability of acetylsalicylic acid powder for oral inhalation (I-ASA) with non-enteric-coated chewable aspirin (C-ASA) in…
- Trial name
- NCT05625347
- Testing
- single dose (100 mg) of ASA, single dose (162 mg) of non-enteric-coated chewable aspirin tablets
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- Vectura, Inc.
HIV Infections
Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Dolutegravir 50mg film-coated tablets (50mg Dolutegravir) versus Tivicay 50mg film-coated tablets (50mg Dolutegravir) in…
- Trial name
- NCT06450275
- Testing
- Dolutegravir 50 MG Film Coated Tablet, Tivicay 50mg, film-coated tablets
- Where
- Jordan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Peripheral Arterial Disease
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them…
- Trial name
- NCT05894460
- Testing
- Chocolate balloon
- Where
- China
- Volunteers
- 254 people
- Sponsor
- Xuanwu Hospital, Beijing
Nonfunctional Kidney, Renal Cancer
Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization
- Trial name
- NCT06565598
- Testing
- Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy
- Where
- China
- Volunteers
- 150 people
- Sponsor
- The First People's Hospital of Xiushui
Healthy
Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed Condition
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
- NCT01056627
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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
Healthy
Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, 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 Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm Pharmaceutical Industries, Egypt) versus Clatazev 60 mg…
- Trial name
- NCT02756936
- Testing
- Daclatasvir Zeta, Clatazev
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Drug Coated Balloon, Bioresorbable Scaffold
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon [DCB] strategy with bail-out BioResorbable Scaffold [BRS] versus BRS…
- Conditions
- Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention (PCI), Acute Coronary Syndrome (ACS)
- Trial name
- LNB (NCT07038408)
- Testing
- Angioplasty with DCB (bail-out BRS), Angioplasty with BRS
- Where
- Estonia
- Volunteers
- 2,256 people
- Sponsor
- Ceric Sàrl