Clinical trials: BALANCE
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
- Trial name
- NCT01645423
- Testing
- Atorvastatin Calcium Tablets, 80 mg
- Where
- India
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available…
- Trial name
- NCT04267276
- Testing
- Part 1: BI 1265162 - intravenous, Part 2: BI 1265162 - oral
- Where
- Netherlands
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under fasting conditions and to monitor safety of subjects
- Trial name
- NCT01131988
- Testing
- Tacrolimus Capsules
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Breast Cancer, Nonsmall Cell Lung Cancer
A Study of [14C]GB491 in Male Healthy Subjects
This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491.
- Trial name
- NCT05860582
- Testing
- [14C]GB491
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Genor Biopharma Co., Ltd.
Healthy
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions
The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting conditions and to monitor safety of subjects.
- Trial name
- NCT01132027
- Testing
- Tacrolimus Capsules
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants
The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of [14C]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of [14C]-xevinapant as well…
- Trial name
- NCT04962724
- Testing
- Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution), Xevinapant 200 mg (Oral Solution)
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Musculoskeletal Diseases
Medacta NextAR TKA Pivotal Trial
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
- Trial name
- NCT04844879
- Testing
- NextAR TKA system
- Where
- 4 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Medacta International SA
Testosterone Deficiency, Estrogen Deficiency
Use of Infrared Photomodulation for Hormonal Balance (Joovvin' for Hormonal Health)
8-week pilot study looking at the impact of Joovv's infrared photo modulation product on male and female hormone levels.
- Trial name
- NCT04245527
- Testing
- Joovv Infrared Light Device
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ProofPilot
Healthy Subjects
A Study in Healthy Volunteers to Investigate How Much Test Medicine [14C]-Uproleselan is Taken up by the Body When Administered Directly Into the Vein (IV)
The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males.
- Trial name
- NCT03606447
- Testing
- Uproleselan
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- GlycoMimetics Incorporated
ADHD, Fibromyalgia
TD-9855 Mass Balance Study
The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855
- Trial name
- NCT01924143
- Testing
- TD-9855
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Healthy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine…
- Trial name
- NCT02327247
- Testing
- Felodipine, PLENDIL®
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fasting
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions
To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation (Plavix® 300 mg tablets) in healthy, adult…
- Trial name
- NCT01621750
- Testing
- Clopidogrel
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg)…
- Trial name
- NCT04454918
- Testing
- TAK-906 Oral Capsule, [14C]-TAK-906 Intravenous Infusion, [14C]-TAK-906 Oral Solution
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Type 2 Diabetes, Obesity
Balance System Study in Type 2 Diabetic Patients
To evaluate the safety and performance of the BALANCE System in treating patients who have type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood pressure and other clinical and metabolic…
- Trial name
- NCT00872846
- Testing
- BALANCE System intestinal electrical stimulator
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Beta-Stim Ltd.
Vestibulopathy
Therapeutic Effects of Electrical Vestibular Stimulation (EVS) on Balance and Gait
The aim of the study to is determine the safety, feasibility, efficacy, and persistence of non-invasive EVS to improve balance and gait performance in healthy individuals across the lifespan.
- Trial name
- VST (NCT06846047)
- Testing
- electrical vestibular stimulation (EVS)
- Where
- 4 sites in United States, Canada
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Neursantys Inc
Solid Tumor
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
- Trial name
- NCT03804515
- Testing
- 14C-labeled poziotinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Chronic Stroke Survivors
Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial.
Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.
- Trial name
- NCT06470009
- Testing
- Portable Neuromodulation Stimulator (PoNS)
- Where
- 3 sites in Canada
- Volunteers
- 60 people
- Sponsor
- Helius Medical Inc
Bioequivalence
Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of…
- Trial name
- NCT06331715
- Testing
- Palbociclib 125mg
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Megalabs
Healthy Volunteers
Excretion Balance, PK and Metabolism of a Single Oral Dose of [14C]PCO371
This is a Phase I single center, open-label, non-randomized study in healthy male subjects, designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability of single oral doses of PCO371.
- Trial name
- NCT04649216
- Testing
- PCO371, [14C]PCO371
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Chugai Pharmaceutical
Schizophrenia
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.
- Trial name
- NCT07455084
- Testing
- 14C-SEP-380135
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.