Clinical trials: BALANCE
Molecular Mechanisms of Pharmacological Action
A Study to Investigate the Mass Balance of BTD-001
This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.
- Trial name
- HV103 (NCT03107013)
- Testing
- [14C]-BTD-001
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Balance Therapeutics
Alzheimer Disease
Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812
- Trial name
- COG0108 (NCT05225389)
- Testing
- 300 mg [C14] CT1812
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cognition Therapeutics
Hypovolemia
Comparison of Two Gelatine Solutions
The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions.
- Trial name
- NCT01515397
- Testing
- Gelofusine balanced, Gelofusine 4%
- Where
- 2 sites in Germany
- Volunteers
- 40 people
- Sponsor
- B. Braun Melsungen AG
Bipolar I Disorder
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder.
- Trial name
- NCT07540338
- Testing
- AL001, Lithium carbonate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alzamend Neuro, Inc.
Healthy Subjects
A Study to Evaluate ACT-132577 in Healthy Male Subjects
The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces
- Trial name
- NCT03100591
- Testing
- 14C-radiolabeled ACT-132577
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Polycystic Ovary Syndrome
A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
This is a virtual, open-label, 2-armed study that will last 6 months. All participants will take the supplements daily and complete questionnaires at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24 (study may be…
- Trial name
- NCT05875233
- Testing
- Elix Daily Harmony, Elix Cycle Balance
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Zenchi, Inc.
Advanced Solid Tumor
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
The study was conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study was to provide a quantitative characterization of the mass balance, rates and routes of elimination…
- Trial name
- NCT05246111
- Testing
- [14C]Berzosertib, Berzosertib, Topotecan
- Where
- 2 sites in Hungary
- Volunteers
- 6 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed 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 fed conditions.
- Trial name
- NCT02322658
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Primary Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Kidney Failure, Chronic
Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers
The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg).
- Trial name
- NCT00875017
- Testing
- Lanthanum Carbonate, Sevelamer
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy Male Subjects
A Mass Balance Study of TS-172 in Healthy Adult Subjects
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-172 after single oral dose of [14C] TS-172 in Japanese healthy male subjects.
- Trial name
- NCT06596356
- Testing
- [14C] TS-172
- Where
- Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Metabolism of Radioactive Substances
A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men
The main purpose of this clinical trial is to quantitatively analyse the total radioactivity in the excreta of subjects after oral administration of [14C]XY0206, and to obtain data on human radioactive excretion rate and main…
- Trial name
- NCT06823232
- Testing
- [14C]XY0206
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
Asthma
An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604
The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma. Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes that carry air in and out of the lungs, causing…
- Trial name
- NCT06157255
- Testing
- AZD4604 Inhalation Powder, 1 mg, [14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL), [14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Epilepsy
Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects
Primary Objectives: To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-sodium valproate (VPA) .
- Trial name
- NCT03681158
- Testing
- sodium valproate
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fasting…
- Trial name
- NCT01581775
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
HIV Infections
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
- Trial name
- NCT07636928
- Testing
- VH4524184, [14C]VH4524184 microdose, [14C]VH4524184
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Dry Eye Disease
Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye
The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to…
- Trial name
- NCT06323395
- Testing
- Vizol S LIPID BALANCE eye drops, ophthalmic saline eye drops
- Where
- 2 sites in Serbia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jadran Galenski laboratorij d.d.
Healthy
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
- Trial name
- NCT02674295
- Testing
- Esketamine 50 mg, Esketamine 20 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Chronic Renal Failure
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.
- Trial name
- NCT01753154
- Testing
- Solution B (balance PD solution), Solution A (conventional PD solution)
- Where
- 7 sites in Poland, Spain
- Volunteers
- 25 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Malignant Melanoma
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients…
- Trial name
- NCT01164891
- Testing
- RO5185426
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- Hoffmann-La Roche