Search clinical trials for: EU-Prolia®

Total 14222 results

Shanghai Henlius Biotech

Completed

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects

Healthy Male Volunteers

China
Xentria, Inc.

Not yet recruiting

Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

Healthy Participants
Luye Pharma Group Ltd.
Parexel

Completed

A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

Healthy

Germany
Enzene Biosciences Ltd.
Alkem Laboratories Ltd

Recruiting

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Healthy Male Subjects

Bulgaria, Poland
Sandoz
Hexal AG

Completed

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

Postmenopausal Women With Osteoporosis

United States, Bulgaria, Czechia, Japan, Poland, Spain
Asahi Kasei Pharma Corporation

Completed

Collagenase Option for Reduction of Dupuytren's Contracture in Japan (CORD-J)

Dupuytren's Contracture

Japan
Celltrion

Completed

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

Healthy Male Subjects

Australia
Bio-Thera Solutions

Active, not recruiting

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

Healthy Men

China
Mishaela Rubin

Terminated

Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab

Diabetes Mellitus, Type 2 | Osteoporosis

United States
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Healthy

Germany
Karolinska Institutet
Karolinska University Hospital

Completed

Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

Pelvic Organ Prolapse

Sweden, Norway, Denmark, Finland
Acrobio Healthcare Inc.

Unknown

Herbal Supplement Prosta-OK® Neo as an Adjunct Therapy in Patients With Mild to Severe Non-neurogenic Male Lower Urinary Tract Symptoms Receiving Tamsulosin Therapy

Lower Urinary Tract Symptoms

Taiwan
Johns Hopkins University
Ohio State University; Henry Ford Health System; Rhode Island Hospital; Virginia... and other collaborators

Completed

A Randomized Cross-over Study for Normal Pressure Hydrocephalus (ARCS NPH)

Normal Pressure Hydrocephalus

United States
Chinese University of Hong Kong

Completed

RA Denosumab on Bone Microstructure Study

Rheumatoid Arthritis

Hong Kong
Amgen
One Amgen Center Drive; THOUSAND OAKS; CA; 91320-1799; USA

Completed

Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

Osteoporosis, Postmenopausal

Czechia, Slovakia
Vrije Universiteit Brussel
University of British Columbia; University of Coimbra; Amsterdam UMC, location... and other collaborators

Not yet recruiting

International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study) (EU NAVIGATE)

Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative
BioFactura Australia Pty Ltd.
Avance Clinical Pty Ltd.

Completed

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults

Psoriasis

Australia, New Zealand
Sanofi Pasteur, a Sanofi Company

Completed

Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

Poliomyelitis | Polio

Japan
Universitair Ziekenhuis Brussel

Terminated

Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard

Hypoxia | Hypercapnia | Anaemia

Belgium
Mabwell (Shanghai) Bioscience Co., Ltd.

Completed

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults (MW031)

Osteoporosis, Postmenopausal

China
mAbxience Research S.L.

Completed

Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.

Healthy Volunteers

Australia, New Zealand
Shanghai Henlius Biotech

Completed

A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects

Healthy

China
Shanghai Henlius Biotech

Active, not recruiting

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Postmenopausal

China
University of North Carolina, Chapel Hill

Completed

A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers (IRB 09-0259)

Healthy | Cigarette Smoking

United States
Ruhr University of Bochum

Completed

Tachosil for the Prevention of Symptomatic Lymph Cysts

Cervical Cancer | Endometrial Cancer

Austria, Germany
Fresenius Kabi SwissBioSim GmbH

Completed

MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Hungary, Serbia, Georgia, Russian Federation, Slovakia, Czechia, Bulgaria, Moldova, Republic of, Poland
Amgen

Completed

Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

Cancer | Cataract | Prostate Cancer | Osteoporosis | Osteopenia | Low Bone Mineral Density

United States, Canada, Czechia, Poland, Russian Federation, Slovakia, Hungary, South Africa, Greece, Bulgaria, France, Ukraine, Australia, Latvia, India, Slovenia, New Zealand, Mexico
Shanghai Biomabs Pharmaceutical Co., Ltd.

Completed

Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

Postmenopausal Osteoporosis

China
Gan and Lee Pharmaceuticals, USA

Completed

PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Diabetes Mellitus, Type 1

Germany
Gedeon Richter Plc.

Completed

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

Postmenopausal Osteoporosis

Poland, United States, Spain, Hungary, Italy, Czechia, Bulgaria, Ukraine
Amgen

Completed

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Osteoporosis
Universita di Verona
University of Southern California

Completed

Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance (FMD_Exercise)

Diet, Healthy | Fasting | Fatigue, Mental | Fatigue; Muscle, Heart

Italy
Sanofi Pasteur, a Sanofi Company

Completed

REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

Tetanus | Diphtheria | Poliomyelitis

France
Teva Pharmaceuticals USA
Teva Branded Pharmaceutical Products R&D, Inc.

Completed

A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

Osteoporosis, Postmenopausal

United States, Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Russian Federation, Slovakia, Ukraine
Celltrion

Recruiting

A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Healthy Subjects

Korea, Republic of
ISU Abxis Co., Ltd.

Completed

A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers

Gaucher Disease

Australia
University Hospital Inselspital, Berne

Completed

The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 | Exercise

Switzerland
Northumbria University
Naturex SA

Completed

To Assess the Influence of Aronox on Parameters Associated With Recovery Following Muscle Damaging Exercise

Muscle Damage

United Kingdom
Biocon Biologics UK Ltd
Biotrial

Completed

Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (DENARIUS)

Healthy Volunteers

United States
Biocon Biologics UK Ltd

Active, not recruiting

Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (DEVOTE)

Postmenopausal Women With Osteoporosis

United Kingdom
Qilu Pharmaceutical Co., Ltd.

Unknown

Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults

Healthy People

China
Gan and Lee Pharmaceuticals, USA

Completed

PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

Diabetes Mellitus

Germany
mAbxience Research S.L.

Active, not recruiting

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)

Postmenopausal Women With Osteoporosis

Poland, Serbia, Bulgaria, Georgia, Estonia, Hungary, Latvia, Mexico
Kunming Pharmaceuticals, Inc.

Unknown

Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

Healthy
Hope Rugo, MD
University of California, San Francisco; Amgen

Terminated

Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer

Early Stage Breast Cancer

United States
Shanghai Biomabs Pharmaceutical Co., Ltd.

Recruiting

Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

Postmenopausal Osteoporosis

China
Northumbria University
Naturex

Completed

To Assess the Influence of Aronox on Parameters Associated With Aerobic Performance

Aerobic Capacity

United Kingdom
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis

Poland
Fresenius Kabi SwissBioSim GmbH

Completed

Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

Healthy

New Zealand

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