Clinical Trials Sponsored by Impax Laboratories, LLC

Total 134 results

Romark Laboratories L.C.

Completed

A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza

Influenza

United States, Australia, Puerto Rico
Romark Laboratories L.C.

Terminated

Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Influenza

United States
Romark Laboratories L.C.

Completed

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Influenza

United States, Australia, Belgium, Canada, New Zealand
Romark Laboratories L.C.

Completed

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Rotavirus Infection | Viral Gastroenteritis Due to Rotavirus

Egypt
Romark Laboratories L.C.

Completed

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Diarrhea

Peru
Romark Laboratories L.C.

Completed

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C (STEALTHC-1)

Chronic Hepatitis C

Egypt
Romark Laboratories L.C.

Completed

Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Chronic Hepatitis C

Egypt
Romark Laboratories L.C.

Completed

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Clostridium Difficile

United States
Romark Laboratories L.C.

Completed

Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

Chronic Hepatitis C

Egypt
Romark Laboratories L.C.

Completed

Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents

Amebiasis

Egypt
Qure Healthcare, LLC
Ethos Laboratories

Completed

Establishing Clinical Utility of a New Diagnostic Test for Patients Suffering From Pain: A CPV® Randomized Controlled Trial

Pain | Pain, Chronic

United States
Romark Laboratories L.C.

Not yet recruiting

Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

COVID-19
Romark Laboratories L.C.

Recruiting

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Rhinovirus | Enterovirus

United States
Romark Laboratories L.C.

Completed

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

COVID-19 | Viral Respiratory Illnesses

United States
Romark Laboratories L.C.

Completed

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

COVID-19

United States
Romark Laboratories L.C.

Completed

Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B

Chronic Hepatitis B

Singapore
Romark Laboratories L.C.

Terminated

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

COVID-19 | Viral Respiratory Illnesses

United States
Romark Laboratories L.C.

Completed

Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Rhinovirus | Enterovirus

United States, Puerto Rico
Romark Laboratories L.C.

Completed

Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Influenza

United States, Australia, Puerto Rico
Romark Laboratories L.C.

Terminated

Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Clostridium Infections

United States
Romark Laboratories L.C.

Completed

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients (STEALTHC-3)

Chronic Hepatitis C

United States
Romark Laboratories L.C.

Terminated

Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

Crohn's Disease

United States
Romark Laboratories L.C.

Completed

Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Rotavirus Infection | Norovirus Infection | Adenoviridae Infection
Romark Laboratories L.C.

Completed

4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C

Chronic Hepatitis C

Egypt
Romark Laboratories L.C.

Completed

Study of Nitazoxanide in the Treatment of Amebiasis in Children

Amebiasis

Egypt
Nakhia Impex LLC
Mongolian National University of Medical Sciences

Completed

A Clinical Study of Pain and Discomfort Associated With Advanced Lung Cancer

Advanced Lung Cancer

Mongolia
On Target Laboratories, LLC
SynteractHCR

Completed

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Ovarian Cancer

United States, Netherlands
Xiromed LLC
Laboratorios Liconsa; Exeltis

Completed

Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ARBORUS)

COPD

United States, India
Nakhia Impex LLC
Mongolian National University of Medical Sciences

Completed

Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for the Treatment of Chronic Wounds

Chronic Wounds

China
Sarcoma Oncology Research Center, LLC
Advenchen Laboratories, LLC

Active, not recruiting

Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

Soft Tissue Sarcoma | Small Cell Lung Cancer | Non Small Cell Lung Cancer | Solid Tumor, Adult

United States
On Target Laboratories, LLC
Medelis Inc.

Completed

OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

Lung Neoplasms | Lung Cancer

United States, Netherlands
On Target Laboratories, LLC
Clinipace Worldwide

Completed

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting (Elucidate)

Lung Neoplasms | Lung Cancer

United States
Solae, LLC
Glycemic Index Laboratories, Inc

Completed

Effects of Soy Protein/Soy Fiber on Measures of Satiety

Lack of Satiety

Canada
AbbVie
Janssen Research & Development, LLC; Forest Laboratories

Completed

Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy

Cystic Fibrosis

United States
Wolfson Medical Center
Medical Diagnostic Laboratories, LLC

Unknown

Biomarker Discovery and Application in Bladder Cancer

Bladder Cancer

Israel
Trinitas Global, LLC
AccessDx Laboratories, Houston, TX

Recruiting

INFLAMmatory BiomarkErs in COVID-19 Participants and Severity of Disease (INFLAME COVID)

COVID-19

United States
Vanderbilt-Ingram Cancer Center
Wren Laboratories LLC

Completed

Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Melanoma

United States
SCRI Development Innovations, LLC
Genentech, Inc.; Prometheus Laboratories

Completed

Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer

Breast Cancer

United States
Neuroganics LLC
Neuroganics Diagnostics LLC; Artron Laboratories Inc; AllBio Science Inc.; Turklab

Recruiting

COVID-19 Diagnostic Self-testing Using Virtual Point-of-care

COVID-19 | Infectious Disease | Coronavirus | Sars-CoV2 | Communicable Disease | Virus

United States
University of Washington
Merck Sharp & Dohme LLC; Prometheus Laboratories

Terminated

Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer

Metastatic Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer | Advanced Clear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer

United States
AstraZeneca
Merck Sharp & Dohme LLC; Myriad Genetic Laboratories, Inc.

Completed

Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer (CONCERTO)

Recurrent Platinum Resistant Ovarian Cancer

United States
Amneal Pharmaceuticals, LLC
Accutest Research Laboratories (I) Pvt. Ltd.

Unknown

BE Study in Patients - Methotrexate Tablets

Rheumatoid Arthritis | Psoriasis

India
Amneal Pharmaceuticals, LLC
Accutest Research Laboratories (I) Pvt. Ltd.

Completed

Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions

Chronic Myeloid Leukemia | Gastrointestinal Stromal Tumor

India
Dove Medical Press Ltd
The Affiliated Hospital of Qingdao University; Nakhia Impex LLC

Completed

A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain

Back Pain | Neck Pain | Shoulder Pain | Herpes Zoster Pain | Temporal Pain

China
Amneal Pharmaceuticals, LLC
Accutest Research Laboratories (I) Pvt. Ltd.

Completed

Bioequivalence Fasting Study in Patients

Schizophrenia

India
AstraZeneca
Merck Sharp & Dohme LLC; Myriad Genetic Laboratories, Inc.

Active, not recruiting

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD)

Breast Cancer Metastatic | BRCA 1 Gene Mutation | BRCA 2 Gene Mutation

Italy, Spain, United States, Czechia, Romania, France, Korea, Republic of, United Kingdom, Hungary, Japan, Peru, Poland, Russian Federation, Turkey, China, Taiwan, Bulgaria, Switzerland, Mexico
AstraZeneca
Merck Sharp & Dohme LLC; Myriad Genetic Laboratories, Inc.

Completed

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)

Metastatic Adenocarcinoma of the Pancreas | Germline BRCA1/2 Mutations and

United States, France, Italy, Spain, United Kingdom, Belgium, Canada, Germany, Korea, Republic of, Australia, Israel, Netherlands
AstraZeneca
Merck Sharp & Dohme LLC; Myriad Genetic Laboratories, Inc.

Completed

Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments (SOLO3)

Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

United States, Italy, Spain, Belgium, Poland, Canada, Korea, Republic of, Brazil, Czechia, Hungary, Israel, Argentina, Mexico
AbbVie
Endo Pharmaceuticals; Allergan Sales, LLC; Acerus Pharmaceuticals Corporation; Upsher-Smith...

Completed

A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE)

Cardiovascular Diseases | Hypogonadism

United States, Puerto Rico
Housey Healthcare ULC
Glycemic Index Laboratories, Inc

Completed

Acute Effect of HP-211 (Axulin) on Blood Glucose and Serum Insulin Responses in Healthy Lean and Overweight Humans

Insulin Resistance, Diabetes

Canada

Clinical Trials Sponsored by Impax Laboratories, LLC

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

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Rare Diseases

Drug Interventions

Dietary Supplements

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