Clinical trials: BALANCE
Multiple Sclerosis
Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.
The objectives of this study in Multiple Sclerosis (MS) participants treated with prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated with placebo are to assess the effect over 24 weeks on…
- Trial name
- MOBILE (NCT01597297)
- Testing
- BIIB041 (PR Fampridine)
- Where
- 23 sites in Belgium, Canada and 4 more
- Volunteers
- 132 people
- Sponsor
- Biogen
Smoking Behaviors
Nicotine Pouch Pharmacokinetics Abuse Liability
Nicotine pharmacokinetics and subjective effects of Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
- Trial name
- NCT07476144
- Testing
- Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
- Where
- 2 sites in United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- JT International SA
Sleep Initiation and Maintenance Disorders
Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
The purpose of this study is to define the absorption, breakdown and excretion of a single dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration in blood, urine and faeces over a 7-10 day…
- Trial name
- NCT00520663
- Testing
- 14C-SB649868
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumors, Lymphoma
Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib
The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and…
- Trial name
- NCT01714947
- Testing
- [^14C]-alisertib, alisertib
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
ADME
Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants
This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered [14C]xeruborbactam.
- Trial name
- NCT07083817
- Testing
- [14C]Xeruborbactam
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Healthy
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate capsules, USP 130 mg, of Ohm Laboratories Inc.
- Trial name
- NCT02306889
- Testing
- Fenofibrate, ANTARA® (fenofibrate)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
The main objective of this trial is to Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14) Provide plasma and urine samples for pharmacokinetic…
- Trial name
- NCT05833035
- Testing
- BI 1291583 mixed with [C-14] BI 1291583
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
- Trial name
- NCT07219017
- Testing
- ABBV-1354
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions
This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of…
- Trial name
- NCT00872235
- Testing
- fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing fexofenadine hydrochloride) Orally…
- Trial name
- NCT01888718
- Testing
- Fexofenadine Hydrochloride
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Antithrombic Drug
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under…
- Trial name
- NCT06043297
- Testing
- Apixaban 5MG, Eliquis 5 mg
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Cardiovascular Disease
A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831
The Sponsor is developing the test medicine, AZD4831, for the potential treatment of cardiovascular disease (CVD). CVD is a general term to describe a range of conditions that affect the heart and blood vessels, examples of CVD…
- Trial name
- NCT04407091
- Testing
- 14C]AZD4831 Oral Solution
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 200 mg under fasting conditions
- Trial name
- NCT01673997
- Testing
- Metoprolol Succinate
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
- Trial name
- NCT04183686
- Testing
- ACT-1014-6470 (SAD), ACT-1014-6470 (MAD), 14C-ACT-1014-6470 microtracer
- Where
- Netherlands
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy Volunteers, Healthy
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy.
- Trial name
- NCT03163173
- Testing
- GC4419
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Galera Therapeutics, Inc.
Secondary Hypogonadism
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in…
- Trial name
- NCT02274181
- Testing
- Androxal
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Vestibular Disorder
Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance
The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture.
- Trial name
- NCT02735096
- Testing
- EquiCue (Intraoral Electronic Balance Aid)
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Innervo Technology LLC
Epilepsy
Bioequivalence Study of Perampanel Tablets 10 mg
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 10 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 10 mg film-coated tablets…
- Trial name
- NCT06450236
- Testing
- Perampanel 10 MG, Fycompa 10Mg Tablet
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Chronic Kidney Diseases
A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects
The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]HRS-1780 following an oral single dose in healthy adult male participants.
- Trial name
- NCT07557407
- Testing
- [14C]HRS-1780
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Bronchial Asthma
OC000459 Bronchial Allergen Challenge
OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to…
- Trial name
- NCT01056692
- Testing
- OC000459
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Oxagen Ltd