Clinical trials: Balanced
Healthy
Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fasting…
- Trial name
- NCT01581775
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Cataracts
Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses
The purpose of this study is to demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45°…
- Trial name
- NCT02502526
- Testing
- Centurion® Vision System, 45° Balanced Tip, Centurion® Vision System, 45° MFK Tip, lnfiniti® Vision System, 45° MFK Tip
- Volunteers
- 231 people
- Sponsor
- Alcon Research
Healthy Adult Male Volunteers
ADME Study of [14C]-Jaktinib in Healthy Male Subjects
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]-Jaktinib orally in Chinese healthy male subjects.
- Trial name
- NCT05150717
- Testing
- [14C]-Jaktinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Chronic Constipation
Effects of Oral PEG 3350 on Electrolyte Balance
The study is to evaluate the influence of three different doses of PEG 3350 with or without electrolytes on the electrolyte balance in patient volunteers with confirmed chronic constipation.
- Trial name
- NCT00868985
- Testing
- PEG 3350 plus electrolytes, PEG 3350 without electrolytes
- Where
- Romania
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Norgine
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.
HIV Infection, Infection, Human Immunodeficiency Virus
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body.
- Trial name
- NCT00386347
- Testing
- GSK364735 oral solution and oral tablets
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bipolar I Disorder
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder.
- Trial name
- NCT07540338
- Testing
- AL001, Lithium carbonate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alzamend Neuro, Inc.
Healthy
Copper Balance in Healthy Participants Administered ALXN1840
The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.
- Trial name
- NCT04594252
- Testing
- ALXN1840
- Where
- United Kingdom
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Volunteers
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
- Trial name
- NCT04952467
- Testing
- 14C-XEN1101
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
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 Male Subjects
A Mass Balance Study of TS-172 in Healthy Adult Subjects
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-172 after single oral dose of [14C] TS-172 in Japanese healthy male subjects.
- Trial name
- NCT06596356
- Testing
- [14C] TS-172
- Where
- Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Respiratory Disorders, Asthma and Rhinitis
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator…
- Trial name
- NCT02658422
- Testing
- Test Montelukast, Reference Montelukast
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream.
- Trial name
- NCT01448395
- Testing
- [14C]NXL104
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Type 2 Diabetes
Bioequivalence Study to Compare Imeglimin HCl 500 mg Film Coated Tablets Versus Twymeeg Tablets 500 mg
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of Imeglimin HCl 500 mg Film Coated Tablets of Humanis Sağlık A.Ş., Ç.O.S.B.
- Trial name
- NCT07691177
- Testing
- Imeglimin Hydrochloride Film Coated Tablet, TWYMEEG® Tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.
- Trial name
- NCT01380561
- Testing
- asimadoline
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Tioga Pharmaceuticals
Healthy Subjects
A Mass Balance Study of [14C]ABSK021
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects.
- Trial name
- NCT06186583
- Testing
- Pimicotinib（ABSK021）
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
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
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Bacterial
A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects
This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.
- Trial name
- NCT01648179
- Testing
- GSK1322322 (mesylate salt) Powder for Injection, GSK1322322 (freebase) tablets, GSK1322322 (mesylate salt) Powder for Oral Solution
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hemodialysis Subjects With Secondary Hyperparathyroidism
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013.
- Trial name
- NCT07284043
- Testing
- [14C] MT1013/MT1013 Injection
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.