Clinical trials: BALANCE
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297
- Trial name
- NCT06852092
- Testing
- Carbon-14 labeled HSK39297
- Where
- China
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671709
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects
This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profiling and identification of…
- Trial name
- NCT04098692
- Testing
- Derazantinib capsule, [14C]-Derazantinib solution for infusion, [14C]-Derazantinib capsule
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers
This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg…
- Trial name
- NCT02353299
- Testing
- Silenor 6 mg, zolpidem 10 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Currax Pharmaceuticals
Parkinson Disease
PK Study of WD-1603 in Healthy Subjects
An open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects…
- Trial name
- NCT04591535
- Testing
- WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
- Where
- India
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hong Kong WD Pharmaceutical Co., Limited
IBS, Constipation Predominant
The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation
The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp.
- Trial name
- NCT07094035
- Testing
- food supplement based on a mixture of green tea extract and a pool of probiotics.
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Adamas Biotech S.r.l.
Fasting
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fasting Conditions
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01884896
- Testing
- Metoprolol Succinate ER Tablet 200 mg, 'TOPROL-XL®' ER Tablets 200 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions
The study was an open label, balanced, randomized, two-treatment, four-period, two sequence, single oral dose, crossover, fully replicate bioequivalence study of two formulations of Valsartan 320 mg under fasting conditions.
- Trial name
- NCT02197442
- Testing
- Valsartan
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Mass Balance Study
Mass Balance Study of [14C] D-2570
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body.
- Trial name
- NCT07411742
- Testing
- [14C] D-2570 group
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Parkinson's Disease, Essential Tremor
Movement Disorder Quantification Algorithm Development
The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such…
- Trial name
- NCT01534650
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Great Lakes NeuroTechnologies Inc.
Fasting
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01741623
- Testing
- Bisoprolol Fumarate Tablet 10 mg, Bisoprolol
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Pain
Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.
- Trial name
- NCT00829088
- Testing
- AZD2066
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers
The study aims to understand, using radiolabelled PF-06463922, 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
- NCT02564562
- Testing
- [14C] PF-06463922
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Osteoarthritis
Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective…
- Trial name
- NCT02290119
- Testing
- Sensor-assisted TKR (Verasense), Control - Without the use of Verasense
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Orthosensor, Inc.
Tinnitus, Subjective
Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo
This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.
- Trial name
- QUIET-1 (NCT02315508)
- Testing
- AUT00063
- Where
- 18 sites in United Kingdom
- Volunteers
- 91 people
- Sponsor
- Autifony Therapeutics Limited
Fed
Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study
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 fed conditions and to monitor the adverse…
- Trial name
- NCT01503424
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 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
- NCT05152680
- Testing
- [14C]-NV-5138
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Navitor Pharmaceuticals, Inc.
Pulmonary Disease, Chronic Obstructive
To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult Males
SB-681323 is a p38 MAP kinase inhibitor and is currently under development by GlaxoSmithKline. This will be an open label study conducted at one site.
- Trial name
- NCT00564746
- Testing
- A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323
- Where
- United Kingdom
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dry Eye
Clinical Trial to Compare the Safety and Efficacy of Nanodrop®
Study design: Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation.
- Trial name
- PRO-176/I (NCT04111965)
- Testing
- Nanodrop®, Systane Balance
- Where
- 6 sites in Mexico
- Volunteers
- 126 people
- Sponsor
- Laboratorios Sophia S.A de C.V.
Rheumatoid Arthritis (RA)
A Study of Human Substance Balance and Biotransformation of [14C]SHR0302
The study is being conducted to evaluate the absorption, metabolism and excretion of [14C]SHR0302 in healthy Chinese adult male subjects.
- Trial name
- NCT05047341
- Testing
- SHR0302、[14C]SHR0302
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.