Clinical trials: BALANCE
Healthy Participants
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.
This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled [14C]PF-07321332 in healthy male participants following oral administration with…
- Trial name
- NCT05178654
- Testing
- [14C]PF-07321332
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
PMS, Menstrual Pain
Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms.
- Trial name
- NCT05145257
- Testing
- Elix Cycle Balance
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Zenchi, Inc.
Hypogonadism
Efficacy of an Intranasal Testosterone Product
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
- Trial name
- NCT01252745
- Testing
- 10.0 mg of Testosterone, 4.0% TID, 13.5 mg of Testosterone, 4.5% B.I.D, 11.25 mg of Testosterone, 4.5% T.I.D
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Acerus Pharmaceuticals Corporation
Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy
Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
- Trial name
- NCT06699628
- Testing
- IRL757
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Integrative Research Laboratories AB
Osteoarthritis, Knee, Rheumatoid Arthritis of Knee
Balanced Knee System Clinical Protocol for IRB Approval
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of…
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Post-traumatic Osteoarthritis of Knee Nos, Valgus Deformity
- Trial name
- NCT02362867
- Testing
- Balanced Knee System
- Volunteers
- 500 people
- Sponsor
- Ortho Development Corporation
Bioequivalence, Safety
Oral Bio-equivalence Study
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects…
- Trial name
- NCT05145621
- Testing
- Fingolimod 0.5 mg capsules- Test drug
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Alembic Pharmaceuticals Ltd.
Relapsing-remitting Multiple Sclerosis
Mass Balance Study of MT-1303
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.
- Trial name
- NCT02293967
- Testing
- MT-1303
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Pain
Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)
Primary: To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.
- Trial name
- NCT00496392
- Testing
- Nasal fentanyl
- Where
- Denmark
- Volunteers
- 115 people
- Sponsor
- Nycomed
Healthy
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
- Trial name
- NCT01627834
- Testing
- Ropinirole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Breast Cancer
A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body.
- Trial name
- NCT07320521
- Testing
- [14C]HRS-8080
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy Participants
A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).
- Trial name
- NCT05564208
- Testing
- elafibranor
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Ipsen
Wilson Disease
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
This exploratory study will investigate the effects of ALXN1840 on copper balance in participants with Wilson disease (WD).
- Trial name
- NCT04573309
- Testing
- ALXN1840
- Where
- 3 sites in United States, New Zealand and 1 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Other Endocrine/Nutritional/Metabolic Disorder
Nutritional Supplement Impact on Metabolic Parameters
This open label study seeks to study the effects of a nutritional supplement on inflammatory markers, metabolic parameters, and safety in subjects compared to baseline after taking supplement for 2 and 4 months.
- Trial name
- NCT02349555
- Testing
- Nutritional Supplement Blend
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pharmanex
Impulsive Aggression Comorbid With ADHD
Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers
- Trial name
- NCT02023606
- Testing
- SPN-810M
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Healthy
Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg of OHM Laboratories Inc., USA with ALTACE®…
- Trial name
- NCT00879476
- Testing
- Ramipril 10mg capsules
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers
This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C]-AZD4205.
- Trial name
- NCT04225208
- Testing
- [14C]-AZD4205, single 50 mg oral dose administrated on day 1
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Dizal Pharmaceuticals
Cancer
Study to Investigate the Absorption, Distribution, Metabolism and Elimination of [14C]GSK1120212
GSK1120212 is a reversible and highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity currently being developed for the treatment of malignant melanoma.
- Trial name
- NCT01387204
- Testing
- GSK1120212
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Pharmacokinetics
Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]ZSP1273 in healthy Chinese male participants, revealing the overall…
- Trial name
- NCT05873426
- Testing
- [14C] ZSP1273
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Spinal Cord Injuries, Paraplegia and Tetraplegia
Self-balancing Personal Exoskeleton for SCI (WIP)
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
- Trial name
- NCT07536386
- Testing
- Hands-free exoskeleton
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Wandercraft
Acromegaly
Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral ONO-5788.
- Trial name
- ONO-5788-02 (NCT03849872)
- Testing
- ONO-5788, [14C]-ONO-5788
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.