Clinical Trials Sponsored by BioDirection Inc

Total 35515 results

Mylan Pharmaceuticals Inc

Completed

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay

Healthy

United States
Mylan Pharmaceuticals Inc

Completed

Fed Study of Oxybutynin Chloride Extended-release Tablets 10 mg and Ditropan XL® Tablets 10 mg

Healthy

United States
Mylan Pharmaceuticals Inc

Completed

Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg

Healthy

United States
Mylan Pharmaceuticals Inc

Completed

Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg

Healthy

United States
Mylan Pharmaceuticals Inc

Completed

Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg

Healthy

United States
Mylan Pharmaceuticals Inc

Completed

Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

Healthy

United States
Eisai Korea Inc.

Active, not recruiting

A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures

Epilepsy

Korea, Republic of
EmitBio Inc.
NAMSA

Active, not recruiting

Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting (EB-PCC-01)

Post COVID-19 Condition (PCC)

United States
LENZ Therapeutics, Inc
ORA, Inc.

Completed

Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Eye Diseases | Presbyopia | Miosis | Near Vision

United States
Signos Inc
Lindus Health, Inc.

Active, not recruiting

Using Signos mHealth Platform in Adults for Weight Management (SWEET)

Metabolic Syndrome | Weight Loss | Overweight and Obesity

United States
Eisai Inc.
H3 Biomedicine Inc.

Terminated

Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101

Lymphoma | Advanced Solid Tumors

United States, Spain, France, Korea, Republic of, United Kingdom
Technoderma Medicines Inc.
Therapeutics, Inc.

Completed

Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia

Alopecia, Androgenetic

United States
Encore Research Inc.
CoolSystems, Inc.

Completed

Cryopneumatic Device After Shoulder Surgeries

Shoulder Injuries | Shoulder Disease

Canada
LENZ Therapeutics, Inc
ORA, Inc.

Completed

Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia (CLARITY)

Eye Diseases | Presbyopia | Miosis | Near Vision

United States
NeuroRx, Inc.
Target Health Inc.

Active, not recruiting

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (SBD-ASIB)

Suicidal Ideation | Bipolar Depression

United States
NeuroRx, Inc.
Target Health Inc.

Active, not recruiting

NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression (SevereBD)

Suicidal Ideation | Bipolar Depression

United States
FitBiomics, Inc.
People Science, Inc.

Completed

A Study of the Next-generation Probiotic, Veillonella Atypica FB0054 vs Placebo (ProjectV)

Fatigue

United States
Technoderma Medicines Inc.
Therapeutics, Inc.

Completed

A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects

Healthy

United States
Orthomedico Inc.
ECA Healthcare Inc.

Active, not recruiting

Effects of Consumption of Phosphatidylserine on the Cognitive Function

Healthy Japanese Subjects

Japan
Eisai Korea Inc.

Completed

A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea

Parkinson Disease

Korea, Republic of
LENZ Therapeutics, Inc
ORA, Inc.

Completed

Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

Eye Diseases | Refractive Errors | Presbyopia | Ophthalmic Solutions | Brimonidine Tartrate | Aceclidine

United States
OncoSynergy, Inc.
Infuseon Therapeutics, Inc.

Terminated

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection

Glioblastoma | Glioblastoma Multiforme | High Grade Glioma | Anaplastic Astrocytoma | Glioma, Malignant

United States
Technoderma Medicines Inc.
Therapeutics, Inc.

Completed

A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)

Alopecia, Androgenetic

United States
Lucid Diagnostics, Inc.

Completed

Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE (ESOGUARDBE1)

Barrett Esophagus | Esophageal Adenocarcinoma | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With Dysplasia

United States, Spain
Avulux, Inc.
Imarc Research, Inc.

Completed

Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

Migraine

United States
Aldeyra Therapeutics, Inc.
ORA, Inc.

Completed

A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Conjunctivitis, Allergic

United States
CHDI Foundation, Inc.
Medpace, Inc.

Active, not recruiting

Natural History Study in Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD (SHIELD HD)

Huntington Disease

United States, Canada, France, Germany, United Kingdom
Antibe Therapeutics Inc.
Veristat, Inc.

Completed

Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients

Osteoarthritis

Canada
Mylan Pharmaceuticals Inc

Completed

MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

NSCLC Stage IV

Turkey, Taiwan, Vietnam, Croatia, India, Russian Federation, Spain, Hungary, Bosnia and Herzegovina, Ukraine, Poland, Romania, Belarus, Bulgaria, Georgia, Italy, Philippines
Eisai Inc.
PharmaBio Development Inc.

Terminated

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer

Bladder Cancer

United Kingdom, Netherlands, Spain, Germany, United States, Ukraine
Radius Health, Inc.
Medpace, Inc.

Completed

Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

Healthy Volunteers

United States
Eisai Korea Inc.

Completed

The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

Alzheimer's Disease

Korea, Republic of
Eisai Inc.
PharmaBio Development Inc.

Completed

E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

United States, Korea, Republic of, Ukraine, United Kingdom
Ironwood Pharmaceuticals, Inc.
Medpace, Inc.

Terminated

A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

Gout | Chronic Kidney Disease (CKD)

United States, Hungary, Poland, Czechia
Mirum Pharmaceuticals, Inc.
Clinigen, Inc.

Approved for marketing

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

Alagille Syndrome

United States
Eisai Korea Inc.

Completed

Post-Marketing Surveillance of Lenvima in Korean Patients

Differentiated Thyroid Carcinoma (DTC)

Korea, Republic of
NSABP Foundation Inc
Eisai Inc.

Completed

Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

Breast Cancer | HER2-negative Breast Cancer

United States, Canada
Eisai Korea Inc.

Completed

A Study to Evaluate Alzheimer's Disease Conversion Rate Differences Between High-risk Mild Cognitive Impairment (MCI) and Low-risk MCI in a Real World Setting (CONCORDE)

Mild Cognitive Impairment

Korea, Republic of
Eagle Pharmaceuticals, Inc.
Quintiles, Inc.

Completed

Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

Heat Stroke

Saudi Arabia
Agensys, Inc.

Completed

A Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology

Carcinoma, Renal Cell | Renal Cell Carcinoma of Papillary Histology | Renal Cell Carcinoma With Clear Cell Histology | Renal Cell Carcinoma With Non-Clear Cell Histology

United States, Canada
ORA, Inc.
Palatin Technologies, Inc

Completed

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

Dry Eye Disease

United States
AVEO Pharmaceuticals, Inc.
Biodesix, Inc.

Terminated

A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label (FOCAL)

Non-small Cell Lung Cancer

Korea, Republic of, United States, Australia, Taiwan, Singapore, Hong Kong, Italy
Ocular Therapeutix, Inc.
ORA, Inc.

Completed

OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Chronic Allergic Conjunctivitis
Seagen Inc.
Millennium Pharmaceuticals, Inc.

No longer available

A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

Lymphoma, Non-Hodgkin | Lymphoma, T-Cell, Cutaneous | Lymphoma, Large-Cell, Anaplastic | Disease, Hodgkin

United States, United Kingdom, Belgium, Serbia, Australia, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Spain, Switzerland
EndoCeutics Inc.
AMAG Pharmaceuticals, Inc.

Withdrawn

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

Hypoactive Sexual Desire Disorder (HSDD)

United States
Eisai Korea Inc.

Completed

Halaven Post-Marketing Surveillance (PMS)

Breast Cancer

Korea, Republic of
Astellas Pharma Inc
Seagen Inc.

Completed

A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Metastatic Urothelial Cancer

Japan
Eisai Korea Inc.

Completed

Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization

Epilepsy

Korea, Republic of
Illumina, Inc.
Agility Clinical, Inc.

Completed

A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test

Pregnancy

United States
UpTru Inc.
Medicor Research Inc.

Completed

The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples

Urine Sample Authenticity

Canada

Clinical Trials Sponsored by BioDirection Inc

Sponsors and Collaborators

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CROs in Macedonia

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