Clinical trials: BALANCE
Healthy Participant Study
RE104 Radiolabeled Mass Balance (hAME) Study
The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers.
- Trial name
- NCT07146191
- Testing
- 2-[14C]-RE104 for Injection
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Reunion Neuroscience Inc
Gout, Hyperuricemia
Mass Balance Study of [14C]LC350189 in Healthy Volunteers
This is a Phase 1, open-label, single-dose, mass balance study designed to evaluate the absorption, metabolism, and excretion of [14C] radiolabeled LC350189 after oral administration.
- Trial name
- NCT04070846
- Testing
- [14C] LC350189
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy Subjects
A Mass Balance Study of [14C]ABSK021
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects.
- Trial name
- NCT06186583
- Testing
- Pimicotinib（ABSK021）
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Respiratory Insufficiency
Description of Fluid Balance in Patients With Acute Respiratory Failure
The specific aim of this study is to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a…
- Trial name
- NCT02523872
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Smiths Medical, ASD, Inc.
Healthy Male Subjects
Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects
This study is objective to evaluate the in vivo absorption, excretion and biotransformation pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in…
- Trial name
- NCT04655872
- Testing
- [14C]TPN171H
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Hypercholesterolaemia
Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals.
- Trial name
- NCT01597700
- Testing
- 10mg Ezetimibe, 10 mg Ezetimibe - wash out period
- Where
- India
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Dysmenorrhea, Menstural Cramps
Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.
This study is to evaluate the effects of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
- Trial name
- PD (NCT07529561)
- Testing
- CL25216
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- ApexCPG LLC
Healthy Volunteers
A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers
This is a Phase 1, single-center, randomized, double-blind, active-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and nephrotoxicity attenuation potential of VRP-034 compared with…
- Trial name
- VRP-034 (NCT07502144)
- Testing
- VRP-034 (Polymyxin B 500,000 IU), Commercially available Polymyxin B 500,000 IU (Poly-MxB)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Venus Remedies Limited
Healthy Volunteers
Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839.
- Trial name
- NCT04729309
- Testing
- [12C] RO7049389, [13C] RO7049389, [14C] RO7049389
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Alzheimer's Disease, Dementia With Lewy Bodies
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.
- Conditions
- Alzheimer's Disease, Dementia With Lewy Bodies, Parkinson's Disease Dementia
- Trial name
- NCT02910102
- Testing
- RVT-101 35 mg
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Axovant Sciences Ltd.
Healthy Male Subjects
Mass Balance and Metabolism Study of 14C-Z-215
The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).
- Trial name
- NCT02618629
- Testing
- 14C-Z-215
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Zeria Pharmaceutical
Neoplasms
Investigation of Mass Balance of the Test Drug and Major Metabolites
The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the…
- Trial name
- NCT00432302
- Testing
- Sagopilone (BAY 86-5302, ZK 219477)
- Where
- Belgium
- Volunteers
- 7 people
- Sponsor
- Bayer
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants.
- Trial name
- NCT03918967
- Testing
- CT-G11, CT-G20
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Mass Balance Study of KBP-5074 in Healthy Male Subjects
This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
- Trial name
- NCT04634812
- Testing
- KBP-5074
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
Ovarian Epithelial Cancer Recurrent
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal injection therapy .
- Trial name
- NCT02260544
- Testing
- Doxorubicin Hydrochloride Liposome Injection
- Where
- 11 sites in India
- Volunteers
- 49 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Febrile Neutropenia
A Comparative Evaluation of Pharmacokinetics and Immunogenicity.
The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a…
- Trial name
- NCT06918587
- Testing
- TPI-120 with On body injector, Fylntera
- Where
- Jordan
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT02322645
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fluid Balance
Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women
Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy…
- Trial name
- NCT07217834
- Testing
- Experimental glycerol beverage, kiwi-strawberry flavor
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Healthy
A Clinical Trial to Evaluate [14C]-MK-4208/[14C]-TERN-701 in Healthy Adult Male Participants (MK-4208-002/TERN701-1016)
The goal of the study is to learn what happens to different forms of TERN-701 medications in a healthy person's body over time. Researchers will compare what happens to different forms of TERN-701 in a person's body over time.
- Trial name
- NCT07839000
- Testing
- TERN-701
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy Volunteer
A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers
This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.
- Trial name
- NCT01631422
- Testing
- RO4602522
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche