Clinical trials: Single Layer
Atherosclerosis
A Study to Assess the Effect of SB 659032 on Platelet Function
This will be an open-label, single dose, single period study. Approximately 14 subjects will receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast.
- Trial name
- NCT01750827
- Testing
- SB659032
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Nirmatrelvir \& Ritonavir From Copaxid 150 +100 mg Tablets (Eva…
- Trial name
- NCT05491330
- Testing
- Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose), Nirmatrelvir 150 mg + Ritonavir 100 mg (test), Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
- Where
- Egypt
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Myelofibrosis
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
Primary objective: To evaluate the effect of rabeprazole on the primary pharmacokinetics of TQ05105 tablets. Secondary objective: To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in…
- Trial name
- NCT07608666
- Testing
- TQ05105 tablets, Rabeprazole sodium enteric-coated tablets
- Where
- China
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
- Trial name
- NCT02516098
- Testing
- hyoscine butylbromide
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Prostatic Hyperplasia
Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.
This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg) relative to co-administration of dutasteride…
- Trial name
- ARI115707 (NCT01471678)
- Testing
- Dutasteride (0.5mg), FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg), Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl)
- Where
- Australia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Healthy Volunteer Male Subjects
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg…
- Trial name
- NCT07156916
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Hyperuricemia, Gout
Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets
The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or…
- Trial name
- NCT05168683
- Testing
- Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal, Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Allena Pharmaceuticals
Peripheral Artery Disease
Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity
The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity.
- Trial name
- LEG (NCT02043951)
- Testing
- Lutonix Drug Coated Balloon Catheter
- Where
- 8 sites in Canada, Malaysia and 1 more
- Volunteers
- 59 people
- Sponsor
- C. R. Bard
Healthy
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers.
- Trial name
- NCT01134965
- Testing
- Flibanserin plus Digoxin, Digoxin
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers
This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by PrJSC…
- Trial name
- NCT05663398
- Testing
- Darfen 400, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate), Nurofen® Forte Express, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)
- Where
- Jordan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Complex Lower Extremity Soft Tissue Reconstruction
Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other…
- Trial name
- NCT01947387
- Where
- 4 sites in United States
- Volunteers
- 320 people
- Sponsor
- Integra LifeSciences Corporation
Femoral Artery Stenosis, Popliteal Artery Stenosis
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- CONFIRM (NCT02813577)
- Testing
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
Heartburn
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation.
- Trial name
- NCT00945750
- Testing
- Famotidine FCT, Famotidine CT
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Disease
SELUTION 4 De Novo Small Vessel IDE Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as…
- Trial name
- NCT05946629
- Testing
- PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES
- Where
- 70 sites in United States, Belgium and 1 more
- Volunteers
- 960 people
- Sponsor
- M.A. Med Alliance S.A.
Healthy Participants
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.
- Trial name
- NCT05512806
- Testing
- AZD5462
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Femoropopliteal Occlusive Disease, Peripheral Artery Disease
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.
- Trial name
- KANSHAS-1 (NCT02939924)
- Testing
- Kanshas DCB
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Terumo Europe N.V.
Arteriovenous Fistula
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.
- Trial name
- AVR (NCT02746159)
- Testing
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 320 people
- Sponsor
- C. R. Bard
Atherosclerosis, Vascular Disease
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
- Conditions
- Atherosclerosis, Vascular Disease, Arteriosclerosis
- Trial name
- LEVANT I (NCT00930813)
- Testing
- Lutonix Catheter, Standard uncoated Balloon Angioplasty Catheter
- Where
- 10 sites in Belgium, Germany
- Volunteers
- 101 people
- Sponsor
- C. R. Bard
Healthy Volunteers
Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers
The purpose of this study is to assess bioequivalence of the granule formulation of alpelisib as compared to the film-coated tablet formulation in healthy volunteers in the fed state.
- Trial name
- NCT05195892
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals