Clinical trials: Single Layer
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
Transplant; Failure, Kidney
Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)
The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
- Trial name
- NCT01044303
- Testing
- Myfortic Escalation
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- East Carolina University
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
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
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Ridge Preservation
To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets
This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant…
- Trial name
- NCT04133363
- Testing
- Ridge preservation using L-PRF/FDBA layered technique, Ridge preservation using L-PRF/FDBA, Ridge preservation using L-PRF
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Irritable Bowel Syndrome, Abdominal Pain
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a ileocolonic release peppermint oil and an small intestinal release peppermint oil (Tempocol®).
- Conditions
- Irritable Bowel Syndrome, Abdominal Pain, Colonic Diseases, Visceral Pain
- Trial name
- NCT02291445
- Testing
- Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule), Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
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
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
Healthy Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
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
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 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
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline…
- Trial name
- NCT01235195
- Testing
- sertraline hydrochloride
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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.
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