Clinical trials: BALANCE
Healthy Male Subjects
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of…
- Trial name
- NCT03770039
- Testing
- Oral PF-06700841 containing 14C microtracer, Oral unlabeled PF-06700841, IV 14C-labeled PF-06700841
- Where
- 2 sites in Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Safety
FDA Phase IV - Commitment - Retinal Function Study
Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction. The purpose of this study is to find out if there are any changes in the eye after taking at least 15 doses…
- Trial name
- NCT00461565
- Testing
- Sildenafil, Vardenafil (Levitra, BAY38-9456)
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
Dry Eye, Meibomian Gland Dysfunction
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of…
- Trial name
- NCT05191771
- Testing
- Neovis Total Multi, Systane Balance
- Volunteers
- 120 people
- Sponsor
- Horus Pharma
Diabetes, Healthy
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.
- Trial name
- NCT01527552
- Testing
- biphasic insulin aspart 50
- Where
- South Africa
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Mass Balance Study in Healthy Subjects
Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
- Trial name
- NCT05841940
- Testing
- [14C]HLX208
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Fasting
Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fasting conditions and to monitor the…
- Trial name
- NCT01503398
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
SIRS, Balanced Fluids
Effects of IV Chloride Content on Outcomes
This observational study evaluates the impact of high and low chloride containing IV fluids on administrative and clinical outcomes.
- Conditions
- SIRS, Balanced Fluids, Plasmalyte
- Trial name
- NCT02083198
- Where
- United States
- Volunteers
- 1,558 people
- Sponsor
- Baxter Healthcare Corporation
Healthy Volunteers
A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
- Trial name
- NCT03177278
- Testing
- [14C]-plazomicin
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Achaogen, Inc.
Lymphoma, Non-Hodgkin
A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)
This phase I study is designed to evaluate absorption, metabolism and excretion (AME) profiles of [14C]-DZD8586, to determine the routes, rates of elimination, and mass balance of DZD8586 in healthy adult male participants.
- Trial name
- NCT07454863
- Testing
- DZD8586
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Dizal Pharmaceuticals
Basic Science
A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants
This is an open-label, single-center, single-dose study.
- Trial name
- NCT07460284
- Testing
- 14C-RAY1225
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Food Effect, Mass Balance
A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects
An Study of Orally Administered RNK08954 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of RNK08954，Mass Balance Study of [14C] RNK08954 in Chinese Healthy Adult Male Subjects
- Trial name
- NCT07334262
- Testing
- RNK08954
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
Beta-Thalassemia
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.
- Trial name
- NCT00069862
- Testing
- Deferitrin (GT56-252), desferoxamine (DFO)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Genzyme, a Sanofi Company
Opioid Use Disorder
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
The purpose of this open label study is to characterise the absorption, metabolism, excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male participants.
- Trial name
- NCT05974046
- Testing
- [14C]IDV184001AN
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Healthy Volunteers
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers
Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in healthy male volunteers
- Trial name
- NCT02096679
- Testing
- AZD9291
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions
To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy…
- Trial name
- NCT00776646
- Testing
- hydrochlorothiazide 50 mg tablet
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Contraception, Menopause
Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
- Trial name
- NCT02720224
- Testing
- Estetrol
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Estetra
Dry Eye
Clinical Evaluation of Systane® Balance in Dry Eye Subjects
The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.
- Trial name
- NCT02511379
- Testing
- Propylene Glycol 0.6% eye drops
- Volunteers
- 14 people
- Sponsor
- Alcon Research
Healthy Subjects
Mass Balance Study of [¹⁴C]FXS4640 in Healthy Adult Males
A Single-center, Non-randomized, Open-label, Single-dose Mass Balance Study of [14C]FXS4640 in Healthy Adult Male Participants
- Trial name
- NCT07872579
- Testing
- [¹⁴C]FXS4640
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Healthy Volunteers
A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify major circulating and excreted metabolites.
- Trial name
- NCT03500224
- Testing
- [14C]-TAK-954
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Cardiovascular Disease
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers
The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease. The study is an open-label, single dose study involving 6 healthy male subjects.
- Trial name
- NCT03948451
- Testing
- [14C]AZD5718 Oral Suspension
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca