Clinical trials: Double Layer
Prevention of Stroke or Systemic Embolism, Deep Vein Thrombosis (DVT)
To Compare and Evaluate the Oral Bioavailability of Edoxaban 60 mg Film Coated Tablet With That of Lixiana® 60 mg Filmtabletten (Film Coated Tablet) (Edoxaban) in Healthy, Adult, Human Subjects Under Fasting Conditions
To compare and evaluate the oral bioavailability of Edoxaban 60 mg Film Coated Tablet with that of Lixiana® 60 mg filmtabletten (Film Coated Tablet (Edoxaban) in healthy, adult, human subjects under fasting conditions.
- Conditions
- Prevention of Stroke or Systemic Embolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- Trial name
- NCT06930937
- Testing
- Lixiana® Film Coated Tablet, Edoxaban Film Coated Tablet
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Baricitinib From Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated Tablets (Eli Lilly Nederland B.V., The Netherlands)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Baricitinib from Barcimiant 4 mg Film Coated Tablets (Horus Pharma…
- Trial name
- NCT05006768
- Testing
- Barcimiant, Olumiant (first dose), Olumiant (second dose)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Major Depressive Disorder (MDD)
The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression
The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.
- Trial name
- NCT06827431
- Testing
- Ammoxetine, Sertraline
- Volunteers
- 770 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Carotid Artery Stenosis
Prospective Single Arm CAS - ROADSAVER Study
Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study.
- Trial name
- ROADSAVER (NCT03504228)
- Testing
- Roadsaver
- Where
- 57 sites in Belgium, Czechia and 11 more
- Volunteers
- 1,967 people
- Sponsor
- Terumo Europe N.V.
Crohn's Disease
A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease
This study employs a multicenter, randomized, double-blind, placebo-controlled, parallel-group, continuous treatment design to evaluate the efficacy, safety, PPK characteristics, and PD effects of H021 Enteric-coated Tablets…
- Trial name
- NCT07677514
- Testing
- H021 Enteric-coated Tablets Low-dose Group, H021 Enteric-coated Tablets High-dose Group
- Where
- 24 sites in United States, China
- Volunteers
- 156 people
- Sponsor
- Jiangsu Carephar Pharmaceutical Co., Ltd.
Coronary Artery Disease
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx…
- Trial name
- NCT00232765
- Testing
- CYPHER Sirolimus-Eluting Stent, Uncoated BX VELOCITY Balloon-Expandable Stent
- Where
- United States
- Volunteers
- 1,058 people
- Sponsor
- Cordis US Corp.
Venous Insufficiency
Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency
Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)
- Trial name
- NCT02191163
- Testing
- Antistax®
- Volunteers
- 71 people
- Sponsor
- Boehringer Ingelheim
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Acute Exacerbations of Chronic Bronchitis
A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control
The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.
- Trial name
- NCT02157571
- Testing
- Prulifloxacin, Levofloxacin
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Lee's Pharmaceutical Limited
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Healthy Volunteers
Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study
This study aims to compare the bioavailability of Dimotec 1000 mg film-coated tablet (Test; Keri Pharma Hungary Kft.) with Detralex 1000 mg film-coated tablets (Reference; Les Laboratoires Servier Industrie, France) in healthy…
- Trial name
- Diosmin (NCT07674446)
- Testing
- Dimotec 1000 mg film-coated tablet, Detralex 1000 mg film-coated tablets
- Where
- India
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Keri Pharma Hungary Kft
Healthy
Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential
To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets
- Trial name
- NCT02183285
- Testing
- Pharmaton PHL 00747 soft gelatine capsules, Pharmaton PHL 00747 film-coated tablets
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Major Depressive Disorder (MDD), IBNI617
Probiotic IBNI617 for Moderate to Severe Depression
IBNI617 is a live biotherapeutic product(LBP). This is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial to evaluate the efficacy and safety of IBNI617 in adult patients with major depressive…
- Trial name
- NCT07728253
- Testing
- Live biotherapeutic product
- Where
- China
- Volunteers
- 148 people
- Sponsor
- IBIOME BIOTECHNOLOGY CO., LTD
Attention Deficit Hyperactivity Disorder (ADHD), Anxiety Disorders and Symptoms
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD).
- Trial name
- MEGA (NCT06854601)
- Testing
- Mexidol
- Where
- 14 sites in Russia
- Volunteers
- 333 people
- Sponsor
- Pharmasoft
Gastric Ulcer
A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
- Trial name
- NCT00961350
- Testing
- PA32540, EC Aspirin 325
- Where
- United States
- Volunteers
- 530 people
- Sponsor
- POZEN
Major Depressive Disorder (MDD)
Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression
The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.
- Trial name
- NCT05018013
- Testing
- Ammoxetine hydrochloride enteric-coated tablets, Duloxetine hydrochloride enteric-coated capsules
- Where
- China
- Volunteers
- 240 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
Short Bowel Syndrome
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults.
- Trial name
- NCT04046328
- Testing
- Enteric-Coated Cholestyramine (ECC) Capsule
- Where
- 3 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Pharmascience Inc.