Clinical trials: Balanced
Healthy Adult Male
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 To assess…
- Trial name
- NCT04182958
- Testing
- (14C)-OPC-61815
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease With Deep Brain Stimulation
Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic.
- Trial name
- NCT02080572
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.
Arthritis, Rheumatoid
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.Cc, Vietnam and Mobic® 15 mg…
- Trial name
- BA/BE: 250/12 (NCT01750931)
- Testing
- Meloxicam GSK 15mg, Mobic 15mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03696329
- Testing
- Tetrabenazine Tablets 25 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Advanced Solid Neoplasms, Lymphoma Neoplasms
A Study to Assess Mass Balance, Pharmacokinetics (PK), and Metabolism of Orally Administered [14 C]-TAK-659 in Participants With Advanced Solid Tumor and/or Lymphoma Malignancies
The purpose of this study is to assess the mass balance and to characterize the pharmacokinetics (PK) in plasma and urine, and of total radioactivity in plasma and whole blood following a single oral dose of [14C]-TAK-659…
- Trial name
- NCT03338881
- Testing
- [14C]-TAK-659, TAK-659
- Sponsor
- Calithera Biosciences, Inc
Healthy
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in…
- Trial name
- NCT01132183
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Healthy
Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects
The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.
- Trial name
- NCT00550212
- Testing
- neratinib
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT02322645
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fasting State
Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01577914
- Testing
- Carvedilol Tablets USP 12.5 mg, Carvedilol
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy Adult Male
Clinical Study on the Mass Balance of Clifutinib
To investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of [14C]Clifutinib, the distribution of total radioactivity in whole blood and plasma, and to determine…
- Trial name
- NCT07211165
- Testing
- [14C]Clifutinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Diabetes, Healthy
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.
- Trial name
- NCT01527656
- Testing
- biphasic insulin aspart 70
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hypertension
Effect of Caldine® on Renal Function in Balanced Hypertension
The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies.
- Trial name
- NCT02240641
- Testing
- Lacidipine, Diuretics, antihypertensive drugs
- Volunteers
- 5,417 people
- Sponsor
- Boehringer Ingelheim
Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Lofexidine ADME & Mass Balance in Volunteers
The purpose of this study is to determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine.
- Trial name
- NCT01310296
- Testing
- Lofexidine hydrochloride
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Rheumatoid Arthritis
Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers
The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.
- Trial name
- NCT00711074
- Testing
- AZD5672
- Where
- United Kingdom
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
- Trial name
- NCT02767310
- Testing
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
Healthy Volunteers
A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available…
- Trial name
- NCT04267276
- Testing
- Part 1: BI 1265162 - intravenous, Part 2: BI 1265162 - oral
- Where
- Netherlands
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects
An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects
The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon.
- Trial name
- NCT04241393
- Testing
- Tavapadon tablet, Tavapadon [14C] suspension
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Healthy Volunteers
Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers
A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion…
- Trial name
- NCT04246749
- Testing
- [14C]-CRN00808, CRN00808
- Where
- Netherlands
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Crinetics Pharmaceuticals Inc.