Clinical trials: BALANCE
Healthy
Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01888731
- Testing
- Lamotrigine
- Where
- India
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Mass Balance Study of NV-5138 in Healthy Male Subjects
The objective of this study is to assess the mass balance and routes of excretion of total radioactivity after a single oral dose of 1600 mg [14C]-NV-5138.
- Trial name
- NCT05384977
- Testing
- [14C]-NV-5138
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Healthy
A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP 20 mg manufactured by OHM Laboratories with…
- Trial name
- NCT01079065
- Testing
- Famotidine
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Decreased and Nonspecific Blood Pressure Disorders and Shock
Comparison of HES 130 in Balanced and in Unbalanced Solution
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
- Trial name
- NCT01301469
- Testing
- 6% HES 130/0.42 in plasma adapted Ringer's solution, 6% HES 130/0.4 in a saline solution
- Where
- 4 sites in China
- Volunteers
- 240 people
- Sponsor
- B. Braun Melsungen AG
Pulmonary Disease, Chronic Obstructive
A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444.
The purpose of this study is to characterise the metabolic disposition of radiolabelled GW642444 when administered orally.
- Trial name
- NCT01286831
- Testing
- [14C]GW642444
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Vestibular Disease
Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction
The purpose of this study is to determine whether the BrainPort™ balance device is safe and effective in the treatment of balance disorders in patients with Bilateral Vestibular Dysfunction.
- Trial name
- NCT00254228
- Testing
- Electrotactile sensory substitution
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 60 people
- Sponsor
- Wicab
Chronic Obstructive Pulmonary Disease (COPD), COPD
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects
The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male…
- Trial name
- NCT04756960
- Testing
- CHF6001
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fungal Infection
A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving data in 4 evaluable subjects…
- Trial name
- NCT04804059
- Testing
- [14C]-APX001 Oral Solution, [14C]-APX001 Solution for Infusion
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937
This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of [14C]-BLU-5937.
- Trial name
- NCT05244759
- Testing
- [14C]-BLU-5937
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bellus Health Inc. - a GSK company
Total Knee Arthroplasty
Clinical Utility and Gait Analysis of NextAR System AUS
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation…
- Trial name
- NCT05863741
- Testing
- Implantation of GMK Sphere with conventional instrumentation, Implantation of GMK Sphere using the NextAR guidance system
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- Medacta International SA
Fasting
Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study
To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135 mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt.
- Trial name
- Minocycline (NCT01067001)
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Amneal Pharmaceuticals Co. India Private Limited
Bioequivalence
A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects
The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO Retard (isosorbide -5 -mononitrate extended…
- Trial name
- NCT03557580
- Testing
- IS-5-MN R, IS-5-MN T1, IS-5-MN T2
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers
Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of drug that is recovered over time via different elimination routes of the body, i.e., whole blood, blood cells, plasma, urine, feces…
- Trial name
- NCT02142127
- Testing
- 14C-labelled GFT505 120 mg
- Where
- Belgium
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Genfit
Healthy
A Study to Assess Mass Balance Recovery, Metabolite Profile and Identification of IV and Oral 14C-BC-3781
This is a single-centre, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled BC-3781 administered via…
- Trial name
- NCT03131141
- Testing
- BC-3781
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nabriva Therapeutics AG
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01831687
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
This is a single site, open label, single dose, non-randomized study in healthy male and female subjects. The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.
- Trial name
- NCT01048203
- Testing
- ABR-215050
- Where
- Sweden
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Active Biotech AB
Healthy
A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The Body
The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body…
- Trial name
- NCT02110342
- Testing
- [14C] PF-04449913
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants
The primary objective of this study is to investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of DC-806 containing 3.7 MBq (100 μCi) of [14C]-DC-806 in urine and feces.
- Trial name
- NCT06045000
- Testing
- DC-806, [14C]-DC-806
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Healthy Volunteers
A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall…
- Trial name
- NCT05103241
- Testing
- [14C] GP681
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671722
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited