Clinical trials: BALANCE
Healthy
Human Mass Balance Study With Bilastine
The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta.
- Trial name
- NCT00572611
- Testing
- [14C]-bilastine
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Faes Farma, S.A.
Type 2 Diabetes
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance…
- Trial name
- NCT02353975
- Testing
- SHR3824
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
- Trial name
- NCT02767310
- Testing
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
Healthy Participants
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants.
- Trial name
- NCT06309394
- Testing
- INCB099280
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Type 2 Diabetes Mellitus (T2DM)
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and…
- Trial name
- NCT07266766
- Testing
- Empagliflozin / Metformin HCl XR Tablets, Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Humanis Saglık Anonim Sirketi
Chronic Heart Failure
Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B.…
- Trial name
- NCT06922253
- Testing
- Sacubitril and Valsartan-Test product, Sacubitril and Valsartan-Reference product
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Polycystic Ovarian Syndrome (PCOS)
This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.
The rationale for this study is to observe the impact of a consumer-grade commercially available product called Milamend Hormone Balance on quality of life and hormonal health in women with self-reported symptoms associated with…
- Trial name
- NCT07764328
- Testing
- A dietary supplement powder for women
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- Mila Mend Inc.
Endometriosis Related Pain, Overactive Bladder
A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)
Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally…
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04487431
- Testing
- BAY1817080, [14C]BAY1817080
- Where
- Netherlands
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379
This is a Phase 1, open label study in healthy male participants to study the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 drug following a single oral dose.
- Trial name
- NCT07712718
- Testing
- [14C]-MRM-3379
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
Fluid Retention Due to Heart Failure
A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up
- Trial name
- NCT07681479
- Testing
- [14C]HRS-9057
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Advanced Solid Metastatic Tumor
Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
Open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and its metabolites.
- Trial name
- NCT00503412
- Testing
- AZD2171
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions
The purpose of this study is to 1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets. 2.
- Trial name
- NCT01133470
- Testing
- Fexofenadine HCl + Pseudoephedrine HCl
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Chronic Hepatitis B
A Study to Evaluate the Mass Balance Absorption and AME of VBR
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
- Trial name
- NCT04637139
- Testing
- Vebicorvir (VBR)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Type 2 Diabetes
Bioequivalence Study to Compare Imeglimin HCl 500 mg Film Coated Tablets Versus Twymeeg Tablets 500 mg
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of Imeglimin HCl 500 mg Film Coated Tablets of Humanis Sağlık A.Ş., Ç.O.S.B.
- Trial name
- NCT07691177
- Testing
- Imeglimin Hydrochloride Film Coated Tablet, TWYMEEG® Tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Peripheral Neuropathies, Peripheral Neuropathy Due to Chemotherapy
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better.
- Conditions
- Peripheral Neuropathies, Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy With Type 2 Diabetes, Balance Control in Elderly
- Trial name
- NCT06959277
- Testing
- Walkasins, Fall Prevention Training
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- RxFunction Inc.
Healthy
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in…
- Trial name
- NCT02297854
- Testing
- Valganciclovir Hydrochloride
- Where
- India
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Chronic Kidney Diseases, Magnetic Resonance Imaging
Material Balance Study of TQ-B3525
A clinical study to investigate the absorption, metabolism and excretion of [14C] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects…
- Trial name
- NCT05675202
- Testing
- TQ-B3525
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy Volunteer
A Phase 1 Mass Balance Study of Varegacestat
This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.
- Trial name
- NCT06845852
- Testing
- varegacestat
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing.
- Trial name
- NCT02132130
- Testing
- CGF166
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Bioavailability and Pharmacokinetics
Pharmacokinetic Study of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) After Administration of CreNeuroS® CNS Fish Oil Plus Softgels in Healthy Subjects Under Fasting Conditions
Demographic data, medical and medication history, physical examination, 12-lead ECG, haematology, biochemistry, serology, urine routine analysis, additionally for females serum pregnancy test, hormone assay (FSH) will be done…
- Trial name
- NCT07461649
- Testing
- Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sichuan Credit Pharmaceutical Co., Ltd.