Clinical trials: BALANCE
Diabetes, Diabetes Mellitus, Type 1
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.
- Trial name
- NCT01464099
- Testing
- insulin aspart
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Novo Nordisk A/S
Healthy
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion Of [14C] Fruquintinib
This will be an open-label, single-center study to evaluate pharmacokinetics and safety of HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of HMPL-013 containing approximately 100 microcuries of…
- Trial name
- NCT02689752
- Testing
- fruquintinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
Fed
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01578265
- Testing
- Ondansetron Tablets USP 8 mg, Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)
The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants.
- Trial name
- NCT06777602
- Testing
- [14C] MK-5475
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fed Conditions
The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ranbaxy Laboratories with Coreg 12.5 mg tablets of Glaxosmithkline in healthy, adult, human subjects under fed…
- Trial name
- NCT00775619
- Testing
- Carvedilol 12.5 mg tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions
The objective of this study was to compare and evaluate the single-dose oral bioavailability of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr.
- Trial name
- NCT01267383
- Testing
- Sertraline
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Skin Laxity
Retrospective Evaluation of Combination Treatment With the Ulthera System
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
- Trial name
- NCT02444169
- Testing
- Ultherapy, Incobotulinumtoxin A, Radiesse
- Where
- 5 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Ulthera, Inc
Sensory Peripheral Neuropathy, Balance; Distorted
walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
The purpose of this study is to investigate the long-term effects of Walkasins® use on clinical and subject-reported outcomes of balance and gait function, quality of life, physical activity/participation, pain, and medication…
- Conditions
- Sensory Peripheral Neuropathy, Balance; Distorted, Sensation Disorders
- Trial name
- NCT03538756
- Testing
- Walkasins
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- RxFunction Inc.
Healthy Subjects
An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects
The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon.
- Trial name
- NCT04241393
- Testing
- Tavapadon tablet, Tavapadon [14C] suspension
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Solid Tumor
Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)
This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and…
- Trial name
- NCT06308263
- Testing
- Tuvusertib [14C]Tuvusertib microtracer, Tuvusertib, Tuvusertib + [14C]Tuvusertib microdose bolus injection
- Where
- Hungary
- Volunteers
- 12 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy Subjects, Human Volunteers
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.
- Conditions
- Healthy Subjects, Human Volunteers, Healthy Participants, Bioequivalence
- Trial name
- NCT05519514
- Testing
- Cortiment, Budesonide
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Healthy
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03706300
- Testing
- Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Correction of Moderate to Severe Nasolabial Folds
Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds
Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs.
- Trial name
- NCT03319719
- Testing
- Belotero® Balance with integral lidocaine, Belotero® Balance
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Merz North America, Inc.
Infections, Respiratory Tract
A Study to Investigate the Recovery, Excretion and Pharmacokinetics of [14C]-GSK2140944 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects
This is an open-label, non-randomized, two-period, cross-over, mass balance study that will evaluate the recovery, excretion, and pharmacokinetics of a single intravenous (IV) dose of [14C]-GSK2140944 (Period 1) and a single oral…
- Trial name
- NCT02000765
- Testing
- GSK2140944 for Injection, GSK2140944 Capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01691456
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Pain
A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose
The purpose of the study is to evaluate the routes and rate of elimination and recovery of total radioactivity (TRA) and characterize the Pharmacokinetic (PK) of VX-993 after a single oral dose of 14C-VX-993.
- Trial name
- NCT06886269
- Testing
- 14C-VX-993
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Arthritis, Rheumatoid
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.Cc, Vietnam and Mobic® 15 mg…
- Trial name
- BA/BE: 250/12 (NCT01750931)
- Testing
- Meloxicam GSK 15mg, Mobic 15mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Male Volunteers
A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon.
- Trial name
- NCT07578636
- Testing
- Oral [14C] PF-07799544, Oral Unlabeled PF-07799544, IV [14C] PF-07799544
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Pfizer