Search clinical trials for: Pharmacodynamic and Pharmacokinetic equivalence

Total 471957 results

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 Limited
Profil Institut für Stoffwechselforschung GmbH

Completed

Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects (RHINE-4)

Healthy Volunteers

Germany
AO GENERIUM

Completed

Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair® (NAP)

Healthy Volunteers

Russian Federation
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer

Completed

A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

Neutropenia

Australia
Celltrion

Terminated

Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial (Triad-DLBCL)

Diffuse Large B-Cell Lymphoma

Korea, Republic of
Ionis Pharmaceuticals, Inc.

Not yet recruiting

ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)

Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
Gannex Pharma Co., Ltd.

Not yet recruiting

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects

NASH
Celgene

Not yet recruiting

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity

Healthy Participants

United States
AstraZeneca
Parexel

Recruiting

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).

Opioid Use Disorder

United States
Korea United Pharm. Inc.

Not yet recruiting

A Study to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of UI059 and UIC202201

Gastro-Intestinal Disorder

Korea, Republic of
Guangdong Hengrui Pharmaceutical Co., Ltd

Not yet recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients

Healthy Subjects | Asthmatic Patients
Changchun GeneScience Pharmaceutical Co., Ltd.

Recruiting

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population

Healthy Volunteer | Vasomotor System; Labile

China
Peking Union Medical College Hospital
Xiangya Hospital of Central South University; Ruijin Hospital; China-Japan Friendship...

Recruiting

The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics

Pulmonary Embolism

China
Changchun BCHT Biotechnology Co.
The First Affiliated Hospital of Yunnan University of Traditional Chinese... and other collaborators

Not yet recruiting

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation

Clostridium Tetanus
Jasper Therapeutics, Inc.

Recruiting

A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines (SPOTLIGHT)

Chronic Inducible Urticaria

Germany
Equilibra Bioscience LLC

Recruiting

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B)

Hemophilia A | Hemophilia B | Healthy Participants

United States
Tasly Pharmaceutical Group Co., Ltd

Not yet recruiting

Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure

Heart Failure

China
BeiGene

Not yet recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035

Autoimmune Diseases | Healthy Volunteers | Healthy Subjects | Healthy Participants | Healthy Adult Participants
Biocad

Recruiting

Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)

Axial Spondyloarthritis

Russian Federation, Belarus
IgGenix Australia Pty Ltd

Not yet recruiting

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001

Peanut Allergy
Mozart Therapeutics Australia Pty Ltd

Not yet recruiting

Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

Type 1 Diabetes | Celiac Disease | Healthy Volunteers

Australia
ProGen. Co., Ltd.

Recruiting

A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers

Healthy | Overweight

Korea, Republic of
Dong-A ST Co., Ltd.

Not yet recruiting

Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors
Beijing Suncadia Pharmaceuticals Co., Ltd

Not yet recruiting

Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation

Atrial Fibrillation
BioMarin Pharmaceutical

Recruiting

A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy

Spain, United Kingdom
Anavex Life Sciences Corp.
Cognitive Research Corporation; COGNISION; Hassman Research Institute

Recruiting

A Study of ANAVEX3-71 in Adults With Schizophrenia (SZ-001)

Schizophrenia

United States
AstraZeneca
Parexel

Recruiting

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia

Cardiovascular

United States
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co....

Not yet recruiting

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053

Hyperlipemia
Vesper Biotechnologies ApS

Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001 in Healthy Participants (SORT-IN-1)

Dementia, Frontotemporal

Netherlands
Vertex Pharmaceuticals Incorporated

Recruiting

A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993

Pain

United States
Chipscreen Biosciences, Ltd.

Not yet recruiting

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles and Food Effect of CS32582 Capsules

Healthy

China
CytosinLab Therapeutics Co., Ltd.

Recruiting

CTS2190 Phase I /II Clinical Study in Patients

Pancreatic Cancer | Non-small Cell Lung Cancer | Solid Tumors | Triple-negative Breast Cancer

China
AstraZeneca
Parexel

Not yet recruiting

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia

Cardiovascular

United States
Visterra, Inc.

Recruiting

A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants

Healthy Volunteers

United States
Hemab ApS

Recruiting

A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia

Glanzmann Thrombasthenia

United States, Belgium, France, Italy, Netherlands, United Kingdom
IMBiologics Corp.

Not yet recruiting

A Study of IMB-101 in Healthy Volunteers and Participants With Rheumatoid Arthritis

Rheumatoid Arthritis
Shandong Suncadia Medicine Co., Ltd.

Not yet recruiting

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects

Inflammatory Bowel Disease
Mabscale, LLC

Recruiting

Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Russian Federation
scPharmaceuticals, Inc.

Recruiting

Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

Heart Failure | Fluid Overload

United States
Jasper Therapeutics, Inc.

Recruiting

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) (BEACON)

Chronic Spontaneous Urticaria

United States, Germany
Shanghai Junshi Bioscience Co., Ltd.

Recruiting

A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects

Migraine

China
JMackem Co., Ltd
Seoul National University Hospital

Recruiting

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects

Diabetic Neuropathies | Neuropathic Pain | Post Herpetic Neuralgia

Korea, Republic of
Ionis Pharmaceuticals, Inc.

Recruiting

Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)

Pelizaeus-Merzbacher Disease

France, Netherlands
Bristol-Myers Squibb

Recruiting

A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

Healthy Participants

United States
Gubra A/S
Quotient Sciences

Recruiting

A First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295

Overweight | Healthy Volunteers

United Kingdom
AstraZeneca

Recruiting

A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants

Healthy Participants

United States
Ikaria Bioscience Pty Ltd
SHANGHAI RONA Therapeutics Co.,Ltd.

Not yet recruiting

the Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C

To Reduce the LDL-C Level in Hypercholesteremia Patients
AstraZeneca
Parexel

Recruiting

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese

Healthy Participants

United States, United Kingdom, Germany
AstraZeneca
Parexel

Recruiting

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants

Healthy Participants

United States
Bristol-Myers Squibb

Recruiting

Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (AURORA-HFpEF)

Heart Failure

United States, Spain, Canada, Italy, Poland

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